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Quality Specialist

Job Description

We are looking for an experienced Quality Specialist to join the QA Material and Assembly team at Biogen in Hillerød. You will be part of a group of nine people who has the main responsibility for QA support to Manufacturing Sciences and Assembly, Label & Pack in Hillerød. Furthermore, the job also includes collaboration with external packaging Partners.Primary Responsibilities• QA support for assembly batches for devices and commercial finished products manufactured at our site in Hillerød• Support commercial projects related to product launches, product life cycle development etc.• Close collaboration and daily contact with the Assembly, Label & Pack and support functions both in Hillerød as well as globally in Biogen in Switzerland and in US• Review of documentation, deviations, CAPA, Quality Agreements etc. related to batch disposition• Participate in compliance audits

Qualifications

• You thrive in an international, multi-cultural environment where things are constantly changing • Profound knowledge of Good Manufacturing Practice (GMP) is a requirement and knowledge within ISO 13485 is an advantage• Experience with support on the line to Finished Goods and Assembly • Experience with implementation of Electronic Batch Documentation or QA requirements for IT systems.• Min 5 years of experience from biotech or pharmaceutical industry is preferred and especially experience within assembly processes and devices are an advantage

Education

• Master of Sciences in Pharmacy, Chemistry, Biotechnology, Engineering or equivalent is required

Employment Category: Full-Time Regular

Experience Level: Associate


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329942280Phoenix-ba244add12019-02-20T00:00:00Quality Specialist

Job Description

We are looking for an experienced Quality Specialist to join the QA Material and Assembly team at Biogen in Hillerød. You will be part of a group of nine people who has the main responsibility for QA support to Manufacturing Sciences and Assembly, Label & Pack in Hillerød. Furthermore, the job also includes collaboration with external packaging Partners.Primary Responsibilities• QA support for assembly batches for devices and commercial finished products manufactured at our site in Hillerød• Support commercial projects related to product launches, product life cycle development etc.• Close collaboration and daily contact with the Assembly, Label & Pack and support functions both in Hillerød as well as globally in Biogen in Switzerland and in US• Review of documentation, deviations, CAPA, Quality Agreements etc. related to batch disposition• Participate in compliance audits

Qualifications

• You thrive in an international, multi-cultural environment where things are constantly changing • Profound knowledge of Good Manufacturing Practice (GMP) is a requirement and knowledge within ISO 13485 is an advantage• Experience with support on the line to Finished Goods and Assembly • Experience with implementation of Electronic Batch Documentation or QA requirements for IT systems.• Min 5 years of experience from biotech or pharmaceutical industry is preferred and especially experience within assembly processes and devices are an advantage

Education

• Master of Sciences in Pharmacy, Chemistry, Biotechnology, Engineering or equivalent is required

Employment Category: Full-Time Regular

Experience Level: Associate

2019-03-13T14:53:18.613 Job Description We are looking for an experienced Quality Specialist to join the QA Material and Assembly team at Biogen in Hillerød. You will be part of a group of nine people who has the main responsibility for QA support to Manufacturing Sciences and Assembly, Label Pack in Hillerød. Furthermore, the job also includes collaboration with external packaging Partners.Primary Responsibilities• QA support for assembly batches for devices and commercial finished products manufactured at our site in Hillerød• Support commercial projects related to product launches, product life cycle development etc.• Close collaboration and daily contact with the Assembly, Label Pack and support functions both in Hillerød as well as globally in Biogen in Switzerland and in US• Review of documentation, deviations, CAPA, Quality Agreements etc. related to batch disposition• Participate in compliance audits Qualifications • You thrive in an international, multi-cultural environment where things are constantly changing • Profound knowledge of Good Manufacturing Practice (GMP) is a requirement and knowledge within ISO 13485 is an advantage• Experience with support on the line to Finished Goods and Assembly • Experience with implementation of Electronic Batch Documentation or QA requirements for IT systems.• Min 5 years of experience from biotech or pharmaceutical industry is preferred and especially experience within assembly processes and devices are an advantage Education • Master of Sciences in Pharmacy, Chemistry, Biotechnology, Engineering or equivalent is required Employment Category: Full-Time Regular Experience Level: Associate11Jobnetba244add100000000000IDK_OFIR_02DKDanmark228DKK2019-03-15T00:00:000000https://bit.ly/2QKtgcA0EuropaDanmarkSjælland & øerStorkøbenhavnAllerødEuropaDanmarkSjælland & øerNordsjællandFredensborgEuropaDanmarkSjælland & øerNordsjællandHillerød3435285BIOGEN (DENMARK) NEW MANUFACTURINGApS11Biogen Idec Alle 13400HillerødDKDanmark0DKDanmarkDKDanmark8Fuldtid46Permanent693871JobNet493027149302711000https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=ba244addhttps://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=ba244addhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=ba244add&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=ba244add&page=EmailApplyForm&component=SendApplicationButtonhttps://static.matchwork.com/company/logo/DK/ORS/SoMe/Oevrige/1.jpgEr Øvrige noget for dig? Søg jobbet som Kvalitetsmedarbejder i dag.12007991Dansk3Læse/ tale315218Kvalitetsmedarbejder0Øvrige360114094Biogennoreply@ofir.comDKDanmarkDKDanmark330004831Pharmacovigilance Compliance Specialist within Audits and Inspections in Global SafetyRobot Are you ready to assume a coordinating role for planning, conduct and follow-up on pharmacovigilance (PV) audits and inspections, working independently with a high degree of flexibility, high level of responsibility whilst influencing and interacting with many different types of people, at all levels of the organisation? If you find challenges like this exciting and inspiring, you may be our new Compliance Specialist, working within audits and inspections in Global Safety, Denmark and our affiliates globally. About the department The position is located in Global Safety Compliance, which is part of the QPPV Office under Global Safety. Global Safety is globally responsible for handling of adverse events, monitoring product safety, customer complaints and potential recalls in Novo Nordisk. The primary responsibilities of the Global Safety Compliance department are ICSR Compliance Tracking, Safety Data Exchange Agreements, Pharmacovigilance System Master File, Regulatory Surveillance, coordination of PV Audits and Inspections, support to HQ functions and affiliates, including handling of safety in Patient Support Programs, Market Research Programs and Digital Health initiatives. We are 10 colleagues with different professional background ensuring support to the Qualified Person for Pharmacovigilance in Novo Nordisk, Global Safety and affiliates worldwide. The job You are accountable for coordinating and supporting the activities related to PV audits and inspections in Global Safety and affiliates. This includes coordination of preparation, on-site support during the inspection, coordination of response preparation and submission to the Competent Authorities and timely closure of corrective and preventive actions (CAPAs). You will drive the audit and inspection processes in the department and ensure they are following regulatory expectations and best practice. You will be expected to perform trending of PV related findings on a continuously basis and proactively communicate trends to management and relevant stakeholders. In addition, you will maintain and provide oversight of the PV training programmes for affiliates. Strong collaboration with our stakeholders in Global Safety, Affiliates, Regulatory Affairs, Global Development and Corporate Quality and Audit function is essential for the role to ensure that the quality system is functioning properly, and we are always inspection ready. Ensuring safe products and compliance is at the heart of Novo Nordisk s business. You can make a great difference by further developing this area and serving as a role model for compliant behaviour. Since you will support the affiliates during PV inspections, you can expect some travel per year. Qualifications You hold a Master s degree with a scientific background. You have extensive knowledge of PV principles and regulatory requirements, broad hands-on experience within PV from various positions, previous proven experience in audits and inspections, and at least general knowledge of GCP and GMP requirements including GxP documentation. You are open-minded, highly motivated and visionary within the field of expertise, with the ability to work independently and drive your job responsibilities. You have strong analytical skills and demonstrated ability to identify better practice and create improvements. You have a strong drive and are able to coordinate complex tasks with often short deadlines. You are a team-player, have excellent cooperation skills, and are used to work with people who have very diverse professional and or cultural background. The role requires a strong quality mind set, ability to focus on details and adherence to standards, while maintaining a balanced business perspective. You are fluent in both written and spoken English at a specialist level. The application should be written in English. At Novo Nordisk we use our skills, dedication and drive to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment. Contact For further information, please contact Mette Stockner 45 30 75 69 38. Deadline 22 April 2019 Millions rely on us To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

Are you ready to assume a coordinating role for planning, conduct and follow-up on pharmacovigilance (PV) audits and inspections, working independently with a high degree of flexibility, high level of responsibility whilst influencing and interacting with many different types of people, at all levels of the organisation? If you find challenges like this exciting and inspiring, you may be our new Compliance Specialist, working within audits and inspections in Global Safety, Denmark and our affiliates globally.

 

About the department

The position is located in Global Safety Compliance, which is part of the QPPV Office under Global Safety. Global Safety is globally responsible for handling of adverse events, monitoring product safety, customer complaints and potential recalls in Novo Nordisk. 

The primary responsibilities of the Global Safety Compliance department are ICSR Compliance Tracking, Safety Data Exchange Agreements, Pharmacovigilance System Master File, Regulatory Surveillance, coordination of PV Audits and Inspections, support to HQ functions and affiliates, including handling of safety in Patient Support Programs, Market Research Programs and Digital Health initiatives. We are 10 colleagues with different professional background ensuring support to the Qualified Person for Pharmacovigilance in Novo Nordisk, Global Safety and affiliates worldwide.  

 

The job

You are accountable for coordinating and supporting the activities related to PV audits and inspections in Global Safety and affiliates. This includes coordination of preparation, on-site support during the inspection, coordination of response preparation and submission to the Competent Authorities and timely closure of corrective and preventive actions (CAPAs). You will drive the audit and inspection processes in the department and ensure they are following regulatory expectations and best practice. You will be expected to perform trending of PV related findings on a continuously basis and proactively communicate trends to management and relevant stakeholders. In addition, you will maintain and provide oversight of the PV training programmes for affiliates. Strong collaboration with our stakeholders in Global Safety, Affiliates, Regulatory Affairs, Global Development and Corporate Quality and Audit function is essential for the role to ensure that the quality system is functioning properly, and we are always inspection ready. 

Ensuring safe products and compliance is at the heart of Novo Nordisk's business. You can make a great difference by further developing this area and serving as a role model for compliant behaviour. 

Since you will support the affiliates during PV inspections, you can expect some travel per year.

 

Qualifications

You hold a Master’s degree with a scientific background. You have extensive knowledge of PV principles and regulatory requirements, broad hands-on experience within PV from various positions, previous proven experience in audits and inspections, and at least general knowledge of GCP and GMP requirements including GxP documentation. 

You are open-minded, highly motivated and visionary within the field of expertise, with the ability to work independently and drive your job responsibilities. You have strong analytical skills and demonstrated ability to identify better practice and create improvements. You have a strong drive and are able to coordinate complex tasks with often short deadlines. You are a team-player, have excellent cooperation skills, and are used to work with people who have very diverse professional and/or cultural background. 

The role requires a strong quality mind set, ability to focus on details and adherence to standards, while maintaining a balanced business perspective. You are fluent in both written and spoken English at a specialist level. 

The application should be written in English. 

At Novo Nordisk we use our skills, dedication and drive to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.

 

Contact

For further information, please contact Mette Stockner +45 30 75 69 38.

 

Deadline

22 April 2019 

 

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

NOVO NORDISK A/SBagsværd2019-04-11T00:00:002019-04-22T00:00:00
330008010GMP Quality Engineer to improve quality in investment engineering projectsRobot Improving food and health for more than 1 billion people every day requires dedicated teamwork. Join us! At Chr. Hansen we work to improve food and health, and our natural ingredients are consumed by more than 1 billion people every day. For this to come true we operate integrated global production and supply chain networks using sophisticated technologies and processes. Automation, robotics and IT systems are key components but the key ingredient is efficient people teams focused on delivering to our customers. As a global market leader in bioscience, we have the opportunity to address important global challenges such as food waste, healthy living, sustainable agriculture and we need the smartest and most passionate people on board to succeed. Want to join us? A career with Chr. Hansen Joining Chr. Hansen is your opportunity to make a meaningful difference while working for a global market leader. Our employees are our most valuable asset. We want to create a friendly and inspiring work environment, where our people feel as engaged as possible in their daily work. This means no matter which of our operations sites you will be based at you will experience a team based, non-hierarchical and agile organization. We are proud to promote an inspiring and safe work environment and a collaborative culture full of passion to make a difference. GMP Quality Engineer to improve quality in investment engineering projects This is a unique chance to work with qualification and documentation in building and equipment investment projects ranging from small to large investments (several million Euros). The product classes range from animal feed through foodstuff, to pharma and infant formula. You will join an agile team of 5 skilled and dedicated colleagues working across the global Chr. Hansen organization. We work with many exciting projects in a very dynamic environment where we can see and feel the results of our work. Even though we are busy, we always have time to help and share knowledge. We work as a team, we win as a team and we celebrate as a team. The role Working as Quality Engineer you must thrive in a dynamic setup where your experience and personality help you deliver professional and effective results. This includes the ability to plan and prioritize the work and keep an overview of the processes. You will be working across all engineering disciplines. This takes good people skills and communication skills in English, written and spoken. As such, you can transmit your personal enthusiasm and quality mindset to other people around you and ensure deliveries according to plans and deadlines. Your primary tasks, within areas of responsibility, will be: Review of User Requirement Specifications URS, FAT, SAT, IQ, OQ protocols and test plans Support engineering package owners in structuring deliverables according to Validation Master Plan Maintain relevant SOPs and Forms in the Quality Management System (QMS) Support preparation of internal and external audits Train others in good documentation practice Maintain training plans Review of qualification test results and deviations Participate in audits inspections on site and assist at audits of external partners You will be based at our Avedoere site in the Copenhagen area, but you can expect to be located at our sites in Roskilde and Hoersholm while participating in projects. Your profile You come with an educational background from engineering or life science and are comfortable to set the Quality direction in collaboration with stakeholders. You must have relevant GMP equipment qualification and validation experience (min 2 years) and capabilities to ensure compliance with our internal SOPs. Gathering, reviewing and organizing critical documentation across several work packages will be your primary tasks. For more information and application If you have any questions about the position, please feel free to contact Ole Hoejgaard, Team Manager, Team Q on dkolh@chr-hansen.com. Deadline for applications is April 28th 2019.

Improving food and health for more than 1 billion people every day requires dedicated teamwork. Join us!

At Chr. Hansen we work to improve food and health, and our natural ingredients are consumed by more than 1 billion people every day.

For this to come true we operate integrated global production and supply chain networks using sophisticated technologies and processes. Automation, robotics and IT systems are key components but the key ingredient is efficient people teams focused on delivering to our customers.

As a global market leader in bioscience, we have the opportunity to address important global challenges such as food waste, healthy living, sustainable agriculture – and we need the smartest and most passionate people on board to succeed. Want to join us?

 

A career with Chr. Hansen 
Joining Chr. Hansen is your opportunity to make a meaningful difference while working for a global market leader.

Our employees are our most valuable asset. We want to create a friendly and inspiring work environment, where our people feel as engaged as possible in their daily work. This means no matter which of our operations sites you will be based at you will experience a team based, non-hierarchical and agile organization. We are proud to promote an inspiring and safe work environment and a collaborative culture full of passion to make a difference.

 

GMP Quality Engineer to improve quality in investment engineering projects
This is a unique chance to work with qualification and documentation in building and equipment investment projects ranging from small to large investments (several million Euros). The product classes range from animal feed through foodstuff, to pharma and infant formula. 

You will join an agile team of 5 skilled and dedicated colleagues working across the global Chr. Hansen organization. We work with many exciting projects in a very dynamic environment where we can see and feel the results of our work. Even though we are busy, we always have time to help and share knowledge. We work as a team, we win as a team and we celebrate as a team.

 

The role
Working as Quality Engineer you must thrive in a dynamic setup where your experience and personality help you deliver professional and effective results. This includes the ability to plan and prioritize the work and keep an overview of the processes.  

You will be working across all engineering disciplines. This takes good people skills and communication skills in English, written and spoken. As such, you can transmit your personal enthusiasm and quality mindset to other people around you and ensure deliveries according to plans and deadlines. 

 

Your primary tasks, within areas of responsibility, will be: 

  • Review of User Requirement Specifications URS, FAT, SAT, IQ, OQ protocols and test plans
  • Support engineering package owners in structuring deliverables according to Validation Master Plan  
  • Maintain relevant SOPs and Forms in the Quality Management System (QMS)
  • Support preparation of internal and external audits
  • Train others in good documentation practice
  • Maintain training plans  
  • Review of qualification test results and deviations
  • Participate in audits/inspections on site and assist at audits of external partners

 

You will be based at our Avedoere site in the Copenhagen area, but you can expect to be located at our sites in Roskilde and Hoersholm while participating in projects.

 

Your profile
You come with an educational background from engineering or life science and are comfortable to set the Quality direction in collaboration with stakeholders.  

You must have relevant GMP equipment qualification and validation experience (min 2 years) and capabilities to ensure compliance with our internal SOPs. Gathering, reviewing and organizing critical documentation across several work packages will be your primary tasks.  

 

For more information and application
If you have any questions about the position, please feel free to contact Ole Hoejgaard, Team Manager, Team Q on dkolh@chr-hansen.com.

Deadline for applications is April 28th 2019.

CHR HANSEN A/SHørsholm2019-04-15T00:00:002019-04-28T00:00:00
330005162GCP Quality Auditor / Specialist, Bagsvaerd DenmarkRobot Pioneer a brighter future At Novozymes, we work in close partnership with our customers and the global community to make a sustainable impact. We use science to advance industries, and as part of Research, Innovation and Supply, you will help find the biological answers and build the new businesses that can pave the way for a brighter future. GCP Quality Auditor Specialist, Bagsvaerd Denmark We are looking for an experienced GCP quality colleague to the department Global QA Compliance Quality EMA to develop an appropriate GCP quality system and audit program. The system is to include all activities of sponsor, monitor and audits of clinical studies both for internal and external activities. Besides developing the quality system, you will act as primary QA representative for assigned projects and be responsible for scheduling and conducting CRO evaluations approval as well as study related audits. This is a 12 month temporary hire opportunity for an experienced GCP Quality Auditor Specialist. The position is based in Bagsvaerd Denmark with reporting line to Department Manager of Global QA Compliance Quality EMA. The position requires close collaboration with relevant sites with GCP activities (Bagsvaerd Denmark and Berlin Germany), as well as interaction with relevant internal stakeholders and subcontractors including project management, data management, monitors, CRO QA etc. In this position you need to: develop quality system and prepare SOPs perform sponsor audits at clinical sites CRO s and partners audit on-going studies, systems and documents to assure quality assurance compliance with regard to ICH FDA GCP, SOPs, and national local guidelines ensure the timely and effective follow up of all identified or assigned quality issues develop and maintain Study Audit Plans and to act as a QA Representative for allocated projects manage CAPAs from audits and non-audit sources perform internal training Qualifications: minimum qualification of a life sciences degree or appropriate previous work experience minimum experience of 3 years in a GCP environment, with at least 2 years as a Clinical QA Auditor or relevant experience a thorough knowledge of ICH GCP and relevant European Directives FDA guidelines and other national guidelines regulations excellent communication and interpersonal skills attention to detail and structured in work able to travel on average 2 days month fluency in English is a prerquisite About Novozymes Novozymes is the world leader in biological solutions. Together with customers, partners and the global community, we improve industrial performance while preserving the planet s resources and helping build better lives. As the world s largest provider of enzyme and microbial technologies, our bioinnovation enables higher agricultural yields, low-temperature washing, energy-efficient production, renewable fuel and many other benefits that we rely on today and in the future. We call it Rethink Tomorrow. www.novozymes.com. Ranked 3 in Science magazine s global Top Employers Survey 2018. Contact For more information please contact Sonia Skotner, Department Manager, Global QA Compliance Quality EMA by phone ( 45) 3077 5781 or by e-mail SOC@NOVOZYMES.COM. Application deadline: 22 April 2019 but please send your application already today, as we are continuously screening the applicants. Please attach a copy of your diploma (mandatory) when you apply for the position. Ref: 6039BR City: Bagsværd Country: Denmark Job Area: Quality, Environmental and Health

Pioneer a brighter future
At Novozymes, we work in close partnership with our customers and the global community to make a sustainable impact. We use science to advance industries, and as part of Research, Innovation and Supply, you will help find the biological answers and build the new businesses that can pave the way for a brighter future.


GCP Quality Auditor / Specialist, Bagsvaerd Denmark
We are looking for an experienced GCP quality colleague to the department; Global QA Compliance & Quality EMA to develop an appropriate GCP quality system and audit program. The system is to include all activities of sponsor, monitor and audits of clinical studies both for internal and external activities. Besides developing the quality system, you will act as primary QA representative for assigned projects and be responsible for scheduling and conducting CRO evaluations/approval as well as study related audits.

This is a 12 month temporary hire opportunity for an experienced GCP Quality Auditor / Specialist. The position is based in Bagsvaerd Denmark with reporting line to Department Manager of Global QA Compliance & Quality EMA. The position requires close collaboration with relevant sites with GCP activities (Bagsvaerd Denmark and Berlin Germany), as well as interaction with relevant internal stakeholders and subcontractors including project management, data management, monitors, CRO QA etc.


In this position you need to:

  • develop quality system and prepare SOPs
  • perform sponsor audits at clinical sites/CRO’s and partners
  • audit on-going studies, systems and documents to assure quality assurance compliance with regard to ICH/FDA GCP, SOPs, and national/local guidelines
  • ensure the timely and effective follow up of all identified or assigned quality issues
  • develop and maintain Study Audit Plans and to act as a QA Representative for allocated projects
  • manage CAPAs from audits and non-audit sources
  • perform internal training


Qualifications:

  • minimum qualification of a life sciences degree or appropriate previous work experience
  • minimum experience of 3 years in a GCP environment, with at least 2 years as a Clinical QA Auditor or relevant experience
  • a thorough knowledge of ICH GCP and relevant European Directives/FDA guidelines and other national guidelines/regulations
  • excellent communication and interpersonal skills
  • attention to detail and structured in work
  • able to travel on average 2 days/month
  • fluency in English is a prerquisite


About Novozymes
Novozymes is the world leader in biological solutions. Together with customers, partners and the global community, we improve industrial performance while preserving the planet’s resources and helping build better lives. As the world’s largest provider of enzyme and microbial technologies, our bioinnovation enables higher agricultural yields, low-temperature washing, energy-efficient production, renewable fuel and many other benefits that we rely on today and in the future. We call it Rethink Tomorrow. www.novozymes.com.


Ranked #3 in Science magazine’s global Top Employers Survey 2018.


Contact
For more information please contact Sonia Skotner, Department Manager, Global QA Compliance & Quality EMA by phone (+45) 3077 5781 or by e-mail SOC@NOVOZYMES.COM. Application deadline: 22 April 2019 but please send your application already today, as we are continuously screening the applicants.
Please attach a copy of your diploma (mandatory) when you apply for the position.

Ref: 6039BR
City: Bagsværd
Country: Denmark
Job Area: Quality, Environmental and Health

NOVOZYMES A/SBagsværd2019-04-11T00:00:002019-04-22T00:00:00
330004835Senior Analytical ProfessionalRobot In Oral Finished Products (OFP) we have set the ambitious target of being first to market with a tablet containing a new GLP-1 drug. Do you want to join us on a journey where you, as a true pioneer, will break new land? You can look forward to a job where you will set direction for the future work in a recently established department and where your effort will have invaluable importance for the lives of people living with diabetes. About the department In Oral Finished Products Quality Control (OFP QC) we count approximately 55 highly skilled and motivated colleagues. Our department delivers analytical support to oral protein products used for clinical phase 3 towards launch of the product. After launch, we will continuingly be supporting the production of oral finished products as well as prepare for new oral products, giving analytical support to manufacturing development. Our department has recently been established and therefore we are in an ongoing process of setting up and impacting working procedures. The position OFP QC is divided in 4 teams you will be part of the team Specific Tablet Analysis, where you as an analytical scientist will approve analytical test results and provide support to HPLC UPLC based methods (e.g. assay, dissolution, impurity, content uniformity), and other methods such as Karl Fischer, UV, disintegration, and Malvern. Qualification of new equipment and validation of methods will also be a part of the job, as well as running projects on relevant matters. You will continuously ensure the optimal performance of the analyses and apply LEAN principles to trouble shoot and improve our working procedures. Furthermore, it will be a key task that you communicate and coordinate with stakeholders internally as well as externally within various subject areas. Qualifications You have a background as a pharmacist, cand. scient. or similar, and have a solid background (2 years as a minimum) from a Quality Control Manufacturing Development laboratory working in a GMP regulated environment. You have experience in approval of analytical test results and standardisation of various tablet analyses. Competences within tasks such as method validation, preparing, updating and reviewing instructions (SOP s), Non-Conformity (NC) reports and Change Requests (CR) will be considered as a plus. Experience with project management in a laboratory environment is considered as an advantage but not a demand. As a person you thrive on a high level of flexibility and with your ability to adapt you will enjoy a position where two days are not alike. You work in a structured manner with a non-compromised focus on quality. At the same time, you appreciate a casual working environment where you with your dedication, good mood and initiative contribute actively to solutions to various types of challenges. Finally, you use your LEAN skills to innovate our working procedures and you work in a systematic and analytical manner to be able to meet deadlines. Working at Novo Nordisk At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information please contact Pernille Hejner at 45 3079 8964. Deadline 29 April Millions rely on us To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

In Oral Finished Products (OFP) we have set the ambitious target of being first to market with a tablet containing a new GLP-1 drug. Do you want to join us on a journey where you, as a true pioneer, will break new land? You can look forward to a job where you will set direction for the future work in a recently established department and where your effort will have invaluable importance for the lives of people living with diabetes.

 

About the department

In Oral Finished Products Quality Control (OFP QC) we count approximately 55 highly skilled and motivated colleagues. Our department delivers analytical support to oral protein products used for clinical phase 3 towards launch of the product. After launch, we will continuingly be supporting the production of oral finished products as well as prepare for new oral products, giving analytical support to manufacturing development. Our department has recently been established and therefore we are in an ongoing process of setting up and impacting working procedures.
 

The position

OFP QC is divided in 4 teams – you will be part of the team Specific Tablet Analysis, where you as an analytical scientist will approve analytical test results and provide support to HPLC/UPLC based methods (e.g. assay, dissolution, impurity, content uniformity), and other methods such as Karl Fischer, UV, disintegration, and Malvern. Qualification of new equipment and validation of methods will also be a part of the job, as well as running projects on relevant matters. 

You will continuously ensure the optimal performance of the analyses and apply LEAN principles to trouble shoot and improve our working procedures. Furthermore, it will be a key task that you communicate and coordinate with stakeholders internally as well as externally within various subject areas.

 

Qualifications

You have a background as a pharmacist, cand. scient. or similar, and have a solid background (2 years as a minimum) from a Quality Control/Manufacturing Development laboratory working in a GMP regulated environment. You have experience in approval of analytical test results and standardisation of various tablet analyses. 

Competences within tasks such as method validation, preparing, updating and reviewing instructions (SOP’s), Non-Conformity (NC) reports and Change Requests (CR) will be considered as a plus. Experience with project management in a laboratory environment is considered as an advantage but not a demand. 

As a person you thrive on a high level of flexibility – and with your ability to adapt you will enjoy a position where two days are not alike. You work in a structured manner with a non-compromised focus on quality. At the same time, you appreciate a casual working environment where you with your dedication, good mood and initiative contribute actively to solutions to various types of challenges. Finally, you use your LEAN skills to innovate our working procedures and you work in a systematic and analytical manner to be able to meet deadlines.

 

Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
 
Contact
For further information please contact Pernille Hejner at +45 3079 8964. 
 

Deadline

29 April

 

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

Novo Nordisk A/SMåløv2019-04-10T00:00:002019-04-29T00:00:00
da-DK

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NOVO NORDISK A/S

Bagsværd
Are you ready to assume a coordinating role for planning, conduct and follow-up on pharmacovigilance (PV) audits and inspections, working independently with a high degree of flexibility, high level of responsibility whilst influencing and interactin...
Indrykket:11. april 2019
Udløbsdato:22. april 2019

GMP Quality Engineer to improve quality in investment engineering projects

CHR HANSEN A/S

Hørsholm
Improving food and health for more than 1 billion people every day requires dedicated teamwork. Join us! At Chr. Hansen we work to improve food and health, and our natural ingredients are consumed by more than 1 billion people every day. For this to...
Indrykket:15. april 2019
Udløbsdato:28. april 2019

GCP Quality Auditor / Specialist, Bagsvaerd Denmark

NOVOZYMES A/S

Bagsværd
Pioneer a brighter future At Novozymes, we work in close partnership with our customers and the global community to make a sustainable impact. We use science to advance industries, and as part of Research, Innovation and Supply, you will help find t...
Indrykket:11. april 2019
Udløbsdato:22. april 2019

Senior Analytical Professional

Novo Nordisk A/S

Måløv
In Oral Finished Products (OFP) we have set the ambitious target of being first to market with a tablet containing a new GLP-1 drug. Do you want to join us on a journey where you, as a true pioneer, will break new land? You can look forward to a job...
Indrykket:10. april 2019
Udløbsdato:29. april 2019