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QA Specialist with experience in biotechnology and quality oversight of external partners

Do you want to use your process knowledge within biotechnology to practice quality oversight of our Contract Manufacturing Organizations?

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. We have an ambitious 2025 strategy, which aims to accelerate our impact in innovative therapeutics.
Part of this journey involve strategic alliances with external partners, for example Contract Manufacturing Organizations (CMO). You will be part the External Manufacturing & Suppliers Quality department and contribute to activities within Supplier Quality Management related to the coming biotechnological products.

In External Manufacturing & Suppliers Quality you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.

The job

The job is a new position established to strengthen our knowledge within biopharmaceutical drug substance and drug product manufacturing. Your responsibilities will be to ensure quality oversight of the manufacturing activities at CMOs. You will collaborate both with internal stakeholders at LEO Pharma and with Quality departments at the different CMOs.

You will

  • build and share knowledge related to area of responsibility
  • practice quality oversight of externally manufactured products, including establishment and update of quality agreements between LEO Pharma and CMOs
  • perform confirmation of partial manufacturing of intermediate or bulk products manufactured by LEO Pharma’s contract manufacturers and make final batch release of contract manufactured products
  • act as QA for activities related to external manufacturing, handle quality events and provide GMP support to stakeholders
  • participate in different projects related to outsourcing activities

Your position will be in Ballerup, Greater Copenhagen. You should expect around 15-20 days of travelling yearly to CMOs.

Your qualifications

  • Preferably a Masters’ degree in natural science, for example pharmacist or engineer
  • Many years of experience from the pharmaceutical industry
  • Solid and up-to-date knowledge of biopharmaceutical drug substance and drug product processes and with drug-device combination products
  • Solid and up-to-date knowledge of GMP requirements
  • Experience from working within a quality organization and preferably also experience as qualified person (QP)

You possess excellent written and oral communication skills, including English, at a proficient level. You have a strong quality mindset and can accurately analyze complex situations and recommend how to handle these situations to ensure patient safety, product quality and compliance. When you face challenges, you see opportunities and focus on identifying and proposing possible solutions. It is important for the position that you have a continues improvement mindset.

Your new team

External Manufacturing & Suppliers Quality is a department in Global Quality. Your colleagues are a group of very skilled quality experts with focus on Supplier Quality Management and quality oversight of different categories of suppliers such as CMOs, API suppliers, excipient Suppliers, packaging suppliers, service providers and more.
We collaborate with other departments in Global Quality, External Manufacturing and other departments in Product Supply, Procurement, Pharmaceutical Design and Development, Regulatory Affairs and with external suppliers.

Join our mission to help more people achieve healthy skin

Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.

By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.

Contact and application

Please apply at our website. The deadline is 21 February 2020 but send your application as soon as possible since we will start calling candidates for interviews already now. If you have any questions, you are very welcome to contact Eva Møller, Senior Manager, External Manufacturing & Suppliers Quality at + 45 5352 6265.


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330167691Phoenix-7982c15412020-01-29T00:00:00QA Specialist with experience in biotechnology and quality oversight of external partners

Do you want to use your process knowledge within biotechnology to practice quality oversight of our Contract Manufacturing Organizations?

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. We have an ambitious 2025 strategy, which aims to accelerate our impact in innovative therapeutics.
Part of this journey involve strategic alliances with external partners, for example Contract Manufacturing Organizations (CMO). You will be part the External Manufacturing & Suppliers Quality department and contribute to activities within Supplier Quality Management related to the coming biotechnological products.

In External Manufacturing & Suppliers Quality you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.

The job

The job is a new position established to strengthen our knowledge within biopharmaceutical drug substance and drug product manufacturing. Your responsibilities will be to ensure quality oversight of the manufacturing activities at CMOs. You will collaborate both with internal stakeholders at LEO Pharma and with Quality departments at the different CMOs.

You will

  • build and share knowledge related to area of responsibility
  • practice quality oversight of externally manufactured products, including establishment and update of quality agreements between LEO Pharma and CMOs
  • perform confirmation of partial manufacturing of intermediate or bulk products manufactured by LEO Pharma’s contract manufacturers and make final batch release of contract manufactured products
  • act as QA for activities related to external manufacturing, handle quality events and provide GMP support to stakeholders
  • participate in different projects related to outsourcing activities

Your position will be in Ballerup, Greater Copenhagen. You should expect around 15-20 days of travelling yearly to CMOs.

Your qualifications

  • Preferably a Masters’ degree in natural science, for example pharmacist or engineer
  • Many years of experience from the pharmaceutical industry
  • Solid and up-to-date knowledge of biopharmaceutical drug substance and drug product processes and with drug-device combination products
  • Solid and up-to-date knowledge of GMP requirements
  • Experience from working within a quality organization and preferably also experience as qualified person (QP)

You possess excellent written and oral communication skills, including English, at a proficient level. You have a strong quality mindset and can accurately analyze complex situations and recommend how to handle these situations to ensure patient safety, product quality and compliance. When you face challenges, you see opportunities and focus on identifying and proposing possible solutions. It is important for the position that you have a continues improvement mindset.

Your new team

External Manufacturing & Suppliers Quality is a department in Global Quality. Your colleagues are a group of very skilled quality experts with focus on Supplier Quality Management and quality oversight of different categories of suppliers such as CMOs, API suppliers, excipient Suppliers, packaging suppliers, service providers and more.
We collaborate with other departments in Global Quality, External Manufacturing and other departments in Product Supply, Procurement, Pharmaceutical Design and Development, Regulatory Affairs and with external suppliers.

Join our mission to help more people achieve healthy skin

Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.

By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.

Contact and application

Please apply at our website. The deadline is 21 February 2020 but send your application as soon as possible since we will start calling candidates for interviews already now. If you have any questions, you are very welcome to contact Eva Møller, Senior Manager, External Manufacturing & Suppliers Quality at + 45 5352 6265.

2020-02-17T20:51:07.060 Do you want to use your process knowledge within biotechnology to practice quality oversight of our Contract Manufacturing Organizations? LEO Pharma has embarked on a very ambitious journey to become the world s preferred dermatology care partner and that is why we need you. We have an ambitious 2025 strategy, which aims to accelerate our impact in innovative therapeutics. Part of this journey involve strategic alliances with external partners, for example Contract Manufacturing Organizations (CMO). You will be part the External Manufacturing Suppliers Quality department and contribute to activities within Supplier Quality Management related to the coming biotechnological products. In External Manufacturing Suppliers Quality you will get the opportunity to make a significant difference for people with serious skin diseases all over the world. The job The job is a new position established to strengthen our knowledge within biopharmaceutical drug substance and drug product manufacturing. Your responsibilities will be to ensure quality oversight of the manufacturing activities at CMOs. You will collaborate both with internal stakeholders at LEO Pharma and with Quality departments at the different CMOs. You will build and share knowledge related to area of responsibility practice quality oversight of externally manufactured products, including establishment and update of quality agreements between LEO Pharma and CMOs perform confirmation of partial manufacturing of intermediate or bulk products manufactured by LEO Pharma s contract manufacturers and make final batch release of contract manufactured products act as QA for activities related to external manufacturing, handle quality events and provide GMP support to stakeholders participate in different projects related to outsourcing activities Your position will be in Ballerup, Greater Copenhagen. You should expect around 15-20 days of travelling yearly to CMOs. Your qualifications Preferably a Masters degree in natural science, for example pharmacist or engineer Many years of experience from the pharmaceutical industry Solid and up-to-date knowledge of biopharmaceutical drug substance and drug product processes and with drug-device combination products Solid and up-to-date knowledge of GMP requirements Experience from working within a quality organization and preferably also experience as qualified person (QP) You possess excellent written and oral communication skills, including English, at a proficient level. You have a strong quality mindset and can accurately analyze complex situations and recommend how to handle these situations to ensure patient safety, product quality and compliance. When you face challenges, you see opportunities and focus on identifying and proposing possible solutions. It is important for the position that you have a continues improvement mindset. Your new team External Manufacturing Suppliers Quality is a department in Global Quality. Your colleagues are a group of very skilled quality experts with focus on Supplier Quality Management and quality oversight of different categories of suppliers such as CMOs, API suppliers, excipient Suppliers, packaging suppliers, service providers and more. We collaborate with other departments in Global Quality, External Manufacturing and other departments in Product Supply, Procurement, Pharmaceutical Design and Development, Regulatory Affairs and with external suppliers. Join our mission to help more people achieve healthy skin Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow. By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people s lives around the world and at the same time create profitable growth. Contact and application Please apply at our website. The deadline is 21 February 2020 but send your application as soon as possible since we will start calling candidates for interviews already now. If you have any questions, you are very welcome to contact Eva Møller, Senior Manager, External Manufacturing Suppliers Quality at 45 5352 6265.11Jobnet7982c154100000000000IDK_OFIR_02DKDanmark228DKK2020-02-21T00:00:000000https://leopharma.easycruit.com/vacancy/2458409/1275190EuropaDanmarkSjælland & øerStorkøbenhavnAlbertslund3701299LEO PHARMA A/S11Industriparken 552750BallerupDKDanmark0
DKDanmarkDKDanmark
8Fuldtid46Permanent10000894447JobNet5107718510771810029-01-2020000https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=7982c154https://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=7982c154https://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=7982c154&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=7982c154&page=EmailApplyForm&component=SendApplicationButtonhttps://static.matchwork.com/company/logo/DK/ORS/SoMe/jobtitle/315218-69-1.jpgQA Specialist with experience in biotechnology and quality oversight of external partners12008011Dansk3Læse/ tale315218Kvalitetsmedarbejder0Øvrige364050498Evanoreply@ofir.comDKDanmarkDKDanmark330172175Quality expert with experience in quality oversight of external partnersRobot Do you want to use your passion for Quality to practice quality oversight of our Contract Manufacturing Organizations? LEO Pharma has embarked on a very ambitious journey to become the world s preferred dermatology care partner and that is why we need you. Part of this journey involve strategic alliances with external partners, for example Contract Manufacturing Organizations (CMO). You will be part the External Manufacturing Suppliers Quality department and contribute to activities within Supplier Quality Management. In External Manufacturing Suppliers Quality you will get the opportunity to make a significant difference for people with serious skin diseases all over the world. The job The job is a new position established due to the increased number of products from an acquisition, and thereby increased number of suppliers to manage. Your responsibilities will be to ensure quality oversight of the manufacturing activities at CMOs. You will collaborate both with internal stakeholders at LEO Pharma and with Quality departments at the different CMOs. You will build and share knowledge related to area of responsibility practice quality oversight of externally manufactured products establishment and update of quality agreements between LEO Pharma and CMOs act as QA for activities related to external manufacturing, handle quality events and provide GMP support to stakeholders participate in different projects related to outsourcing activities Your position will be in Ballerup, Greater Copenhagen. You should expect around 15-20 days of travelling yearly to CMOs. Your qualifications Preferably a Masters degree in natural science, for example pharmacist or engineer A few years of experience from the pharmaceutical industry Solid and up-to-date knowledge of GMP requirements Experience from working within a quality organization and preferably also experience as qualified person (QP) You possess excellent written and oral communication skills, including English, at a proficient level. You have a strong quality mindset and can accurately analyze complex situations and recommend how to handle these situations to ensure patient safety, product quality and compliance. When you face challenges, you see opportunities and focus on identifying and proposing possible solutions. It is important for the position that you have a continues improvement mindset. Your new team External Manufacturing Suppliers Quality is a department in Global Quality. Your colleagues are a group of very skilled quality experts with focus on Supplier Quality Management and quality oversight of different categories of suppliers such as CMOs, API suppliers, excipient suppliers, packaging suppliers, service providers and more. We collaborate with other departments in Global Quality, External Manufacturing and other departments in Product Supply, Procurement, Pharmaceutical Design and Development, Regulatory Affairs and with external suppliers. Join our mission to help more people achieve healthy skin Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow. By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people s lives around the world and at the same time create profitable growth. Contact and application Please apply at our website. The deadline is 21 February 2020 but send your application as soon as possible since we will start calling candidates for interviews already now. If you have any questions, you are very welcome to contact Eva Møller, Senior Manager, External Manufacturing Suppliers Quality at 45 5352 6265.

Do you want to use your passion for Quality to practice quality oversight of our Contract Manufacturing Organizations?

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. Part of this journey involve strategic alliances with external partners, for example Contract Manufacturing Organizations (CMO). You will be part the External Manufacturing & Suppliers Quality department and contribute to activities within Supplier Quality Management.

In External Manufacturing & Suppliers Quality you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.

 

The job


The job is a new position established due to the increased number of products from an acquisition, and thereby increased number of suppliers to manage. Your responsibilities will be to ensure quality oversight of the manufacturing activities at CMOs. You will collaborate both with internal stakeholders at LEO Pharma and with Quality departments at the different CMOs.

You will

  • build and share knowledge related to area of responsibility
  • practice quality oversight of externally manufactured products
  • establishment and update of quality agreements between LEO Pharma and CMOs
  • act as QA for activities related to external manufacturing, handle quality events and provide GMP support to stakeholders
  • participate in different projects related to outsourcing activities

Your position will be in Ballerup, Greater Copenhagen. You should expect around 15-20 days of travelling yearly to CMOs.

 

Your qualifications

 

  • Preferably a Masters’ degree in natural science, for example pharmacist or engineer
  • A few years of experience from the pharmaceutical industry
  • Solid and up-to-date knowledge of GMP requirements
  • Experience from working within a quality organization and preferably also experience as qualified person (QP)

You possess excellent written and oral communication skills, including English, at a proficient level. You have a strong quality mindset and can accurately analyze complex situations and recommend how to handle these situations to ensure patient safety, product quality and compliance. When you face challenges, you see opportunities and focus on identifying and proposing possible solutions. It is important for the position that you have a continues improvement mindset.

 

Your new team


External Manufacturing & Suppliers Quality is a department in Global Quality. Your colleagues are a group of very skilled quality experts with focus on Supplier Quality Management and quality oversight of different categories of suppliers such as CMOs, API suppliers, excipient suppliers, packaging suppliers, service providers and more.
We collaborate with other departments in Global Quality, External Manufacturing and other departments in Product Supply, Procurement, Pharmaceutical Design and Development, Regulatory Affairs and with external suppliers.

 

Join our mission to help more people achieve healthy skin


Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.

By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.

 

Contact and application


Please apply at our website. The deadline is 21 February 2020 but send your application as soon as possible since we will start calling candidates for interviews already now. If you have any questions, you are very welcome to contact Eva Møller, Senior Manager, External Manufacturing & Suppliers Quality at + 45 5352 6265.

LEO PHARMA A/SBallerup2020-02-05T00:00:002020-02-21T00:00:00
330172174QA professionals with experience from the pharmaceutical industryRobot Do you want to use your passion for Quality to support outsourced activities? LEO Pharma has embarked on a very ambitious journey to become the world s preferred dermatology care partner and that is why we need you. Part of this journey involve strategic alliances with external partners, for example Contract Manufacturing Organizations (CMO). You will be part the External Manufacturing Suppliers Quality department and contribute to activities within Supplier Quality Management. In External Manufacturing Suppliers Quality you will get the opportunity to make a significant difference for people with serious skin diseases all over the world. The job We need to strengthen the department with two temporary positions, both of a twelve-month duration, due to the increased project activity related to outsourcing activities. Your responsibilities will be to support the department with quality matters related to manufacturing activities at CMOs as well as when LEO Pharma act as a CMO. You will collaborate both with internal stakeholders at LEO Pharma and with Quality departments at the different CMOs. You will: build and share knowledge related to the project you will participate in establish and update of quality agreements between LEO Pharma and external partners act as QA for activities related to external manufacturing, handle quality events and provide GMP support to stakeholders update product lists on Distribution Partner Quality Agreements update Standard Operation Procedures Your position will be in Ballerup, Greater Copenhagen. Your qualifications preferably a Masters degree in natural science, for example pharmacist or engineer experience from working within a quality organization in the pharmaceutical industry solid and up-to-date knowledge of GMP requirements You possess excellent written and oral communication skills, including English, at a proficient level. You have a strong quality mindset. When you face challenges, you see opportunities and focus on identifying and proposing possible solutions. It is important for the position that you have a continues improvement mindset. Your new team External Manufacturing Suppliers Quality is a department in Global Quality. Your colleagues are a group of very skilled quality experts with focus on Supplier Quality Management and quality oversight of different categories of suppliers such as CMOs, API suppliers, excipient suppliers, packaging suppliers, service providers and more. We collaborate with other departments in Global Quality, External Manufacturing and other departments in Product Supply, Procurement, Pharmaceutical Design and Development, Regulatory Affairs and with external suppliers. Join our mission to help more people achieve healthy skin Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow. By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people s lives around the world and at the same time create profitable growth. Contact and application Please apply at our website. The deadline is 21 February 2020 but send your application as soon as possible since we will start calling candidates for interviews already now. If you have any questions, you are very welcome to contact Eva Møller, Senior Manager, External Manufacturing Suppliers Quality at 45 5352 6265.

Do you want to use your passion for Quality to support outsourced activities?

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. Part of this journey involve strategic alliances with external partners, for example Contract Manufacturing Organizations (CMO). You will be part the External Manufacturing & Suppliers Quality department and contribute to activities within Supplier Quality Management.

In External Manufacturing & Suppliers Quality you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.

The job

We need to strengthen the department with two temporary positions, both of a twelve-month duration, due to the increased project activity related to outsourcing activities. Your responsibilities will be to support the department with quality matters related to manufacturing activities at CMOs as well as when LEO Pharma act as a CMO. You will collaborate both with internal stakeholders at LEO Pharma and with Quality departments at the different CMOs.

You will:

  • build and share knowledge related to the project you will participate in
  • establish and update of quality agreements between LEO Pharma and external partners
  • act as QA for activities related to external manufacturing, handle quality events and provide GMP support to stakeholders
  • update product lists on Distribution Partner Quality Agreements
  • update Standard Operation Procedures

Your position will be in Ballerup, Greater Copenhagen.

Your qualifications

  • preferably a Masters’ degree in natural science, for example pharmacist or engineer
  • experience from working within a quality organization in the pharmaceutical industry
  • solid and up-to-date knowledge of GMP requirements

You possess excellent written and oral communication skills, including English, at a proficient level. You have a strong quality mindset. When you face challenges, you see opportunities and focus on identifying and proposing possible solutions. It is important for the position that you have a continues improvement mindset.

Your new team

External Manufacturing & Suppliers Quality is a department in Global Quality. Your colleagues are a group of very skilled quality experts with focus on Supplier Quality Management and quality oversight of different categories of suppliers such as CMOs, API suppliers, excipient suppliers, packaging suppliers, service providers and more.
We collaborate with other departments in Global Quality, External Manufacturing and other departments in Product Supply, Procurement, Pharmaceutical Design and Development, Regulatory Affairs and with external suppliers.

Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.

By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.

Contact and application

Please apply at our website.
The deadline is 21 February 2020 but send your application as soon as possible since we will start calling candidates for interviews already now. If you have any questions, you are very welcome to contact Eva Møller, Senior Manager, External Manufacturing & Suppliers Quality at + 45 5352 6265.

LEO PHARMA A/SBallerup2020-02-05T00:00:002020-02-21T00:00:00
330177518Principal Quality Specialist with passion for GCPRobot Would you like to play a key role in LEOs ambitious clinical trial programme? Do you find it exiting to cooperate with colleagues across functional areas? Are you looking for a job where you can get global responsibility and personally impact a team with a super ambitious agenda? Then, this is the job for you! The job You will be part of the Global Quality Business Partner team where you will be working closely together with internal and external stakeholders to ensure LEO s processes and systems are maintained and in line with regulatory expectations and industry best practice. In overview your primary responsibilities will be to: Provide quality expertise and advice to stakeholders on matters related to GCP Coordinate, support and follow-up on regulatory inspections and 3rd party inspections Participate and contribute as quality representative in projects Communicate and assess the impact of regulatory industry practice changes on stakeholders systems, LEO studies projects, data and patients Develop and deliver training in relevant GCPs and LEO Quality Systems You will work across the global organisation and be in contact with numerous people in multiple departments and functions. As part of this, you can also expect minimum 10 travel days per year to meet colleagues and partners. The job is a new position with reference to the Director of External Support Quality. About the department We have the responsibility of being the quality one point of contact to our stakeholders in LEO. Our stakeholders range from Clinical Operations and PV to IT and LEO affiliates around the world. The goal is to provide best-in-class quality expertise, facilitate knowledge sharing and develop pragmatic solutions for potential compliance deficiencies or improvements. You will join a team of dedicated and energetic senior specialists in an informal work environment where everyone is heard. Our aspirations are to excel at executing, being professional and ambitious, while never forgetting to have fun! Your qualifications You are a graduate in pharmacy, engineering or chemistry with strong GCP experience and thorough knowledge in clinical trials and or pre-clinical studies. You should be familiar with quality regulations and have a broad understanding of the entire value chain. If you have pharmacovigilance, combination product and or audit experience, it will naturally benefit your application. You are a self-starting and highly structured person that is able to plan own work and get things finished on time. Working cross-organisational takes strong communication and collaboration skills in combination with an open-minded and pragmatic approach that enables you to understand and respect different views and opinions. Excellent written and oral communication skills. Ability to define risk as it relates to specific non-conformances or trends and work with colleagues to mitigate identified risks. What are you getting in return? By joining the team you will have a unique opportunity for personal and professional development and to contribute to business critical processes. Furthermore, the possibility to have an impact on the department and influence on your own job. Contact and application Please apply at our website. The deadline is 26 February 2020, but please send us your application as soon as possible since we will start calling candidates for interviews already now. If you have any questions, you are very welcome to contact Director Arslan Nejadi 45 41 77 21 05. We look forward to receiving your application.

Would you like to play a key role in LEOs ambitious clinical trial programme? Do you find it exiting to cooperate with colleagues across functional areas? Are you looking for a job where you can get global responsibility and personally impact a team with a super ambitious agenda? Then, this is the job for you!

The job

You will be part of the Global Quality Business Partner team where you will be working closely together with internal and external stakeholders to ensure LEO’s processes and systems are maintained and in line with regulatory expectations and industry best practice.

In overview your primary responsibilities will be to:

  • Provide quality expertise and advice to stakeholders on matters related to GCP
  • Coordinate, support and follow-up on regulatory inspections and 3rd party inspections
  • Participate and contribute as quality representative in projects
  • Communicate and assess the impact of regulatory/industry practice changes on stakeholders systems, LEO studies/projects, data and patients
  • Develop and deliver training in relevant GCPs and LEO Quality Systems

You will work across the global organisation and be in contact with numerous people in multiple departments and functions. As part of this, you can also expect minimum 10 travel days per year to meet colleagues and partners.
The job is a new position with reference to the Director of External & Support Quality.

About the department

We have the responsibility of being the quality one point of contact to our stakeholders in LEO. Our stakeholders range from Clinical Operations and PV to IT and LEO affiliates around the world.
The goal is to provide best-in-class quality expertise, facilitate knowledge sharing and develop pragmatic solutions for potential compliance deficiencies &/or improvements.

You will join a team of dedicated and energetic senior specialists in an informal work environment where everyone is heard.

Our aspirations are to excel at executing, being professional and ambitious, while never forgetting to have fun!

Your qualifications

You are a graduate in pharmacy, engineering or chemistry with strong GCP experience and thorough knowledge in clinical trials and/or pre-clinical studies.

You should be familiar with quality regulations and have a broad understanding of the entire value chain.
If you have pharmacovigilance, combination product and/or audit experience, it will naturally benefit your application.

You are a “self-starting” and highly structured person that is able to plan own work and get things finished on time. Working cross-organisational takes strong communication and collaboration skills – in combination with an open-minded and pragmatic approach that enables you to understand and respect different views and opinions.

Excellent written and oral communication skills. Ability to define risk as it relates to specific non-conformances or trends and work with colleagues to mitigate identified risks.

What are you getting in return?

By joining the team you will have a unique opportunity for personal and professional development and to contribute to business critical processes. Furthermore, the possibility to have an impact on the department and influence on your own job.

Contact and application

Please apply at our website. The deadline is 26 February 2020, but please send us your application as soon as possible since we will start calling candidates for interviews already now.

If you have any questions, you are very welcome to contact Director Arslan Nejadi +45 41 77 21 05.

We look forward to receiving your application.

LEO PHARMA A/SBallerup2020-02-13T00:00:002020-02-26T00:00:00
330175343Medarbejdere til Bygningsstyrelsens Frontdesk og DriftssupportRobot Bygningsstyrelsen søger to medarbejdere til at løse opgaver i frontdesk og driftssupport. Til samme team søger vi en kollega til frontdesk og en kollega til driftssupport. Du vil have arbejdssted i Bygningsstyrelsens lokaler på Kalvebod Brygge, og du bliver en del af Center for Facility Management, hvor vi har fokus på værdier som samarbejde og hjælpsomhed. Bygningsstyrelsen er statens største ejendomsvirksomhed, bygherre og leverandør af statslige arbejdspladser samt facility Management. Bygningsstyrelsens Frontdesk er forankret i vores Center for Facility Management, der leverer bygningsvedligehold og drift samt serviceydelser som bl.a. rengøring, kantine, vagt og sikkerhed m.m. til vores kunder i centraladministrationen. I Frontdesken servicerer vi Bygningsstyrelsens kunder og deres medarbejder som er brugere af vores bygninger og services, ligesom vi understøtter og yder support til vores kolleger i Bygningsstyrelsens forskellige funktioner Dine primære arbejdsopgaver vil være: Besvarelse og visitering af henvendelser via telefon og serviceportal Intern support til kolleger i de forskellige funktioner Dialog med vores leverandører om opgaveløsning samt opfølgning og status på opgaver og projekter Din profil: For begge stillinger kræves det, at du har stærke relationelle kompetencer og kan sikre et smidigt samarbejde i hverdagen. Du trives med at hjælpe andre, og det falder dig naturligt at behandle den enkelte kunde bruger eller kollega med professionalisme, engagement og højt serviceniveau. Du er omstillingsparat og fleksibel i forhold til opgaver og måder at arbejde på, og du befinder dig godt i en dynamisk hverdag, hvor du har indflydelse på rutiner og processer. Din baggrund: Som medarbejder i frontdesk forventer vi, at du har erfaring med driftssystemer, som du kan have opnået på mange måder enten via uddannelse eller arbejdserfaring. Som medarbejder i driftssupport kræves det, at du har kendskab til drift og vedligehold af bygninger og installationer gerne som bygningskonstruktør eller lignende. Herudover forventer vi, at du: har erfaring med kundeservice og kundehåndtering er rutineret bruger af Office-pakken samt proces- og opgavestyringssystemer, og at du er hurtig til at sætte dig ind i nye IT løsninger har forståelse for Facility Management både Hard og Soft har gode mundtlige og skriftlige formuleringsevner er empatisk, serviceminded og en udpræget holdspiller. Arbejdstid og løn Der er tale om to stillinger med opstart snarest muligt og som udgangspunkt ikke senere end den 1. april 2020. Arbejdstiden ligger som udgangspunkt i tidsrummet fra 08:00 -16:00 mandag til fredag. Løn- og ansættelsesvilkår sker efter overenskomst mellem staten og relevant faglig organisation. Bygningsstyrelsen er en styrelse under Transport- og Boligministeriet, og dit ansættelsesområde il derfor være hele ministeriet med til enhver tid tilhørende styrelser. Ansøgning og kontakt Vil du vide mere om stillingen, er du velkommen til at kontakte områdeleder Marianne Sterlie på telefon: 4170 1321 eller e-mail: maest@bygst.dk. Der afholdes løbende samtaler, så send os gerne din ansøgning og CV og eksamenspapirer allerede i dag og senest den 24. februar 2019. Du søger stillingen ved at gå ind på www.bygst.dk job.Bygningsstyrelsen søger to medarbejdere til at løse opgaver i frontdesk og driftssupport.

Til samme team søger vi en kollega til frontdesk og en kollega til driftssupport. Du vil have arbejdssted i Bygningsstyrelsens lokaler på Kalvebod Brygge, og du bliver en del af Center for Facility Management, hvor vi har fokus på værdier som samarbejde og hjælpsomhed.

Bygningsstyrelsen er statens største ejendomsvirksomhed, bygherre og leverandør af statslige arbejdspladser samt facility Management. Bygningsstyrelsens Frontdesk er forankret i vores Center for Facility Management, der leverer bygningsvedligehold og drift samt serviceydelser som bl.a. rengøring, kantine, vagt og sikkerhed m.m. til vores kunder i centraladministrationen.

I Frontdesken servicerer vi Bygningsstyrelsens kunder og deres medarbejder som er brugere af vores bygninger og services, ligesom vi understøtter og yder support til vores kolleger i Bygningsstyrelsens forskellige funktioner

Dine primære arbejdsopgaver vil være:

  • Besvarelse og visitering af henvendelser via telefon og serviceportal
  • Intern support til kolleger i de forskellige funktioner
  • Dialog med vores leverandører om opgaveløsning samt opfølgning og – status på opgaver og projekter
Din profil:
For begge stillinger kræves det, at du har stærke relationelle kompetencer og kan sikre et smidigt samarbejde i hverdagen. Du trives med at hjælpe andre, og det falder dig naturligt at behandle den enkelte kunde / bruger eller kollega med professionalisme, engagement og højt serviceniveau. Du er omstillingsparat og fleksibel i forhold til opgaver og måder at arbejde på, og du befinder dig godt i en dynamisk hverdag, hvor du har indflydelse på rutiner og processer.

Din baggrund:
Som medarbejder i frontdesk forventer vi, at du har erfaring med driftssystemer, som du kan have opnået på mange måder enten via uddannelse eller arbejdserfaring.
Som medarbejder i driftssupport kræves det, at du har kendskab til drift og vedligehold af bygninger og installationer gerne som bygningskonstruktør eller lignende.

Herudover forventer vi, at du:

  • har erfaring med kundeservice og kundehåndtering
  • er rutineret bruger af Office-pakken samt proces- og opgavestyringssystemer, og at du er hurtig til at sætte dig ind i nye IT løsninger
  • har forståelse for Facility Management både Hard og Soft
  • har gode mundtlige og skriftlige formuleringsevner
  • er empatisk, serviceminded og en udpræget holdspiller.
Arbejdstid og løn
Der er tale om to stillinger med opstart snarest muligt og som udgangspunkt ikke senere end den 1. april 2020. Arbejdstiden ligger som udgangspunkt i tidsrummet fra 08:00 -16:00 mandag til fredag. Løn- og ansættelsesvilkår sker efter overenskomst mellem staten og relevant faglig organisation. Bygningsstyrelsen er en styrelse under Transport- og Boligministeriet, og dit ansættelsesområde il derfor være hele ministeriet med til enhver tid tilhørende styrelser.

Ansøgning og kontakt
Vil du vide mere om stillingen, er du velkommen til at kontakte områdeleder Marianne Sterlie på telefon: 4170 1321 eller e-mail: maest@bygst.dk. Der afholdes løbende samtaler, så send os gerne din ansøgning og CV og eksamenspapirer allerede i dag og senest den 24. februar 2019. Du søger stillingen ved at gå ind på www.bygst.dk/job.

BygningsstyrelsenKøbenhavn V2020-02-10T00:00:002020-02-24T00:00:00
330173483Lean lead & AnalystRobot Role with focus on operation controlling and continuous improvementAre you passionate about datamining and continuous improvement and do you want to be part of building a success story together with an ambitious team? Join a dynamic and international company where everyone is responsible for delivering right and on time as one team! We are looking for a skilled Lean Lead and Analyst who can develop and implement databased reporting throughout Quality Control (QC) and take ownership of system implementation and anchoring across our departments in Copenhagen. Further to support our journey towards integration and seamless processes across the Copenhagen site. About the department With reference to the head of QC -you will join QC consisting of 70 dedicated colleagues in three departments, Microbiology, Bioassay and Chromatography. We are responsible for method validations for early and late stage products, release analysis of clinical and commercial batches as well as analysis of raw materials and stability programs. We are working in an international and customer oriented way to secure fast and reliable support to our customers. The job The role is new and therefore an excellent opportunity for someone truly interested in making a difference. To succeed in the job, you thrive in a fast-paced environment. You have a strong desire to create a foundation, maintain operational excellence and contribute to the development of Quality Control. You naturally create a positive and inspiring environment around you and lead by being the good example. The main responsibilities are Identify, define and drive improvement initiatives Master data management and maintenance Reporting and follow up on QC KPIs Mentor board meetings across departments and teamsAnchor on all optimization projects in QC As Lean Lead and Analyst you Analyze large data sets to identify opportunities for QC Build dashboards using Excel to explain communicate e.g. process performance and identify opportunities for improvement Partner closely with Manufacturing and Quality Assurance teams to create recommendations on optimization opportunities Act as systems thinker, business analyzer, barrier breaker, facilitator and are willing to drive change Provide project leadership and management Possess the ability to see how the parts connect to the whole operation and respond cross-functionally to meet production and business goals, quality standards and company values. Keep the bigger picture in mind at all times, yet you understand the importance of minding the details. The ideal candidate is expected to have A degree in natural science, engineering or supply chain management Solid IT skills - profound understanding of Excel Several years of Lean experience Business controlling experience is an advantage Advanced English and Danish oral and written communications skills ability to communicate with management, peers and subordinates effectively Travel activities up to 10 days per year is possible. AGC offers AGC offers a dynamic working place with good opportunities of working with a varied array of manufacturing tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extent be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC s employees have a flexible attitude and we help each other to reach deadlines together as one team. For further information regarding the position, please do not hesitate to contact Director Casper Berg, telephone 45 41377913. We process the applications as we receive them. Please submit your CV and application as soon as possible and not later than February 23rd 2020. AGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company s team and approach are tailored to each of its client s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of CMC Biologics innovative approach to cell line and process development. Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

Role with focus on operation controlling and continuous improvementAre you passionate about datamining and continuous improvement and do you want to be part of building a success story together with an ambitious team? Join a dynamic and international company where everyone is responsible for delivering right and on time as one team! We are looking for a skilled Lean Lead and Analyst who can develop and implement databased reporting throughout Quality Control (QC) and take ownership of system implementation and anchoring across our departments in Copenhagen. Further to support our journey towards integration and seamless processes across the Copenhagen site.  

About the department
With reference to the head of QC -you will join QC consisting of 70 dedicated colleagues in three departments, Microbiology, Bioassay and Chromatography. We are responsible for method validations for early and late stage products, release analysis of clinical and commercial batches as well as analysis of raw materials and stability programs. We are working in an international and customer oriented way to secure fast and reliable support to our customers.  

The job
The role is new and therefore an excellent opportunity for someone truly interested in making a difference.  To succeed in the job, you thrive in a fast-paced environment. You have a strong desire to create a foundation, maintain operational excellence and contribute to the development of Quality Control. You naturally create a positive and inspiring environment around you and lead by being the good example. 

The main responsibilities are

  • Identify, define and drive improvement initiatives 
  • Master data management and maintenance 
  • Reporting and follow up on QC KPIs 
  • Mentor board meetings across departments and teamsAnchor on all optimization projects in QC

 As Lean Lead and Analyst you

  • Analyze large data sets to identify opportunities for QC
  • Build dashboards using Excel to explain/communicate e.g. process performance and identify opportunities for improvement
  • Partner closely with Manufacturing and Quality Assurance teams to create recommendations on optimization opportunities 
  • Act as systems thinker, business analyzer, barrier breaker, facilitator and are willing to drive change
  • Provide project leadership and management
  • Possess the ability to see how the parts connect to the whole operation and respond cross-functionally to meet production and business goals, quality standards and company values.
  • Keep the bigger picture in mind at all times, yet you understand the importance of minding the details.

 The ideal candidate is expected to have

  • A degree in natural science, engineering or supply chain management
  • Solid IT skills - profound understanding of Excel 
  • Several years of Lean experience 
  • Business controlling experience is an advantage
  • Advanced English and Danish oral and written communications skills; ability to communicate with management, peers and subordinates effectively

 Travel activities up to 10 days per year is possible. 

AGC offers
AGC offers a dynamic working place with good opportunities of working with a varied array of manufacturing tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extent be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team. For further information regarding the position, please do not hesitate to contact Director Casper Berg, telephone +45 41377913. We process the applications as we receive them. Please submit your CV and application as soon as possible and not later than February 23rd 2020.

AGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of CMC Biologics’ innovative approach to cell line and process development. Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

AGC Biologics A/SSøborg2020-02-07T00:00:002020-02-23T00:00:00
da-DK

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