Quality Assurance & Development Specialist

Every month more than 1,5 million new reviews are posted on Trustpilot for one of the thousands of businesses on our review community. It’s no exaggeration to say that we’re growing at lightning speed. Every single day Trustpilot helps consumers choose with confidence while enabling companies to grow their businesses. Behind our global success is a passionate, international team working in a fast-paced, fun, vibrant environment. Does this sound like your kind of workplace?To support Trustpilot’s rapid expansion, we’re looking for a talented Quality Assurance & Development Specialist to join our team in Copenhagen.As our Quality Assurance (“QA”) & Development Specialist, you will be responsible for global Quality & Compliance alignment, training, quality checks and supporting agents across multiple offices. You will work closely together and report to the Global Director of Q&C Operations as well as having a close relationship with the global Q&C teams. Your tasks will be as follows:

Tasks:

  • Quality Assurance audits on Q&C Agents, ensuring managers get feedback to provide to agents and increase global alignment
  • Ensure Q&C teams are aligned globally through providing regular workshops, test alignment through quarterly quizzes, etc.
  • Provide management with quality assurance reports, to identify gaps in alignment across teams and identify ways to resolve gaps and improve the quality of the agents’ work.
  • Train and mentor new Q&C agents and carry out ad-hoc training of the Trustpilot organisation regarding our work to ensure the integrity of our platform.
  • Responsible for knowledge management in Q&C, including our internal knowledge library, Google Team Drive, document standardization, etc.
  • Responsible for creating processes  and making changes for Q&C Operations and Enforcement teams.
  • Create User Guides to assist agents on using the vast number of tools available to the teams
  • Work with the Q&C Content Creator in order to update macros and support articles that accurately reflect Q&C processes.
  • Work closely with our TnT (Tech) Team in order to fix any bugs and propose changes to ensure efficient processes.
  • Reporting and working closely with product teams from different departments on specific projects that have an impact on the Q&C, ensuring Q&C concerns are identified and raised.
  • Back-up other QA team member on Zendesk administration, which includes setting up dashboards/statistical overview, maintaining Zendesk tags/topics/triggers based on current processes, upload macros for agent use, constantly research Zendesk updates that can benefit operations, etc.

Skills:

  • Minimum of 2 year of experience working with Quality Assurance or similar.
  • Great understanding of Quality Assurance and Quality Improvement processes.
  • Experience working with and/or developing processes.
  • Previous experiences in the Compliance sector.
  • Excellent presentation skills and experience in creating reports.
  • Able to work independently and manage multiple projects at once. A proactive approach to task and issue handling is essential.
  • Ability to deal with multiple stakeholders on a regular basis.
  • Solid organisational skills and a keen eye for details.
  • Excellent written communication skills in English. Knowledge of other foreign languages is a plus.
  • Ability to structure your work and deliver results.
  • A can-do person who works efficiently & takes pride in ensuring quality alignment across multiple teams.

Application

Interested in learning more about Trustpilot? Check out our website www.trustpilot.com or stop by The Muse.   

If you see yourself in this role, submit your application in English by clicking below, and make sure to upload a personalised cover letter, in which you describe why you would be our ideal Quality Assurance & Development Specialist.

Trustpilot is a global company and our data practices are designed to ensure that your personally identifiable information is appropriately protected. Please note that your personal information will be transferred, accessed and stored globally as necessary for the uses and disclosures stated in ourPrivacy Policy.

About TrustpilotTrustpilot is a global, online review community that builds trust and increases transparency between consumers and businesses. Currently boasting more than 50 million consumer reviews of 250,000 businesses, Trustpilot produces a TrustScore for businesses based on recent reviews. Trustpilot’s community is live in 25 countries and more than 10,000 consumers sign up to Trustpilot every day. The platform also helps businesses generate insights through customer review data analytics. This can be used to continuously improve business operations, increase customer satisfaction and drive innovation. By enabling businesses to engage directly with customers, Trustpilot aims to set new global standards in consumer to business dialogue. Trustpilot has customers in 65 countries and has developed strong positions in Denmark, Sweden, UK, France, Germany and the Netherlands, as well as the US. With offices in Copenhagen, London, New York, Denver, Berlin, Melbourne and Vilnius Trustpilot’s +700 employees represent 40+ different nationalities.

 


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330033477Phoenix-dc9e056712019-05-28T00:00:00Quality Assurance & Development Specialist

Every month more than 1,5 million new reviews are posted on Trustpilot for one of the thousands of businesses on our review community. It’s no exaggeration to say that we’re growing at lightning speed. Every single day Trustpilot helps consumers choose with confidence while enabling companies to grow their businesses. Behind our global success is a passionate, international team working in a fast-paced, fun, vibrant environment. Does this sound like your kind of workplace?To support Trustpilot’s rapid expansion, we’re looking for a talented Quality Assurance & Development Specialist to join our team in Copenhagen.As our Quality Assurance (“QA”) & Development Specialist, you will be responsible for global Quality & Compliance alignment, training, quality checks and supporting agents across multiple offices. You will work closely together and report to the Global Director of Q&C Operations as well as having a close relationship with the global Q&C teams. Your tasks will be as follows:

Tasks:

  • Quality Assurance audits on Q&C Agents, ensuring managers get feedback to provide to agents and increase global alignment
  • Ensure Q&C teams are aligned globally through providing regular workshops, test alignment through quarterly quizzes, etc.
  • Provide management with quality assurance reports, to identify gaps in alignment across teams and identify ways to resolve gaps and improve the quality of the agents’ work.
  • Train and mentor new Q&C agents and carry out ad-hoc training of the Trustpilot organisation regarding our work to ensure the integrity of our platform.
  • Responsible for knowledge management in Q&C, including our internal knowledge library, Google Team Drive, document standardization, etc.
  • Responsible for creating processes  and making changes for Q&C Operations and Enforcement teams.
  • Create User Guides to assist agents on using the vast number of tools available to the teams
  • Work with the Q&C Content Creator in order to update macros and support articles that accurately reflect Q&C processes.
  • Work closely with our TnT (Tech) Team in order to fix any bugs and propose changes to ensure efficient processes.
  • Reporting and working closely with product teams from different departments on specific projects that have an impact on the Q&C, ensuring Q&C concerns are identified and raised.
  • Back-up other QA team member on Zendesk administration, which includes setting up dashboards/statistical overview, maintaining Zendesk tags/topics/triggers based on current processes, upload macros for agent use, constantly research Zendesk updates that can benefit operations, etc.

Skills:

  • Minimum of 2 year of experience working with Quality Assurance or similar.
  • Great understanding of Quality Assurance and Quality Improvement processes.
  • Experience working with and/or developing processes.
  • Previous experiences in the Compliance sector.
  • Excellent presentation skills and experience in creating reports.
  • Able to work independently and manage multiple projects at once. A proactive approach to task and issue handling is essential.
  • Ability to deal with multiple stakeholders on a regular basis.
  • Solid organisational skills and a keen eye for details.
  • Excellent written communication skills in English. Knowledge of other foreign languages is a plus.
  • Ability to structure your work and deliver results.
  • A can-do person who works efficiently & takes pride in ensuring quality alignment across multiple teams.

Application

Interested in learning more about Trustpilot? Check out our website www.trustpilot.com or stop by The Muse.   

If you see yourself in this role, submit your application in English by clicking below, and make sure to upload a personalised cover letter, in which you describe why you would be our ideal Quality Assurance & Development Specialist.

Trustpilot is a global company and our data practices are designed to ensure that your personally identifiable information is appropriately protected. Please note that your personal information will be transferred, accessed and stored globally as necessary for the uses and disclosures stated in ourPrivacy Policy.

About TrustpilotTrustpilot is a global, online review community that builds trust and increases transparency between consumers and businesses. Currently boasting more than 50 million consumer reviews of 250,000 businesses, Trustpilot produces a TrustScore for businesses based on recent reviews. Trustpilot’s community is live in 25 countries and more than 10,000 consumers sign up to Trustpilot every day. The platform also helps businesses generate insights through customer review data analytics. This can be used to continuously improve business operations, increase customer satisfaction and drive innovation. By enabling businesses to engage directly with customers, Trustpilot aims to set new global standards in consumer to business dialogue. Trustpilot has customers in 65 countries and has developed strong positions in Denmark, Sweden, UK, France, Germany and the Netherlands, as well as the US. With offices in Copenhagen, London, New York, Denver, Berlin, Melbourne and Vilnius Trustpilot’s +700 employees represent 40+ different nationalities.

 

Every month more than 1,5 million new reviews are posted on Trustpilot for one of the thousands of businesses on our review community. It s no exaggeration to say that we re growing at lightning speed. Every single day Trustpilot helps consumers choose with confidence while enabling companies to grow their businesses. Behind our global success is a passionate, international team working in a fast-paced, fun, vibrant environment. Does this sound like your kind of workplace?To support Trustpilot s rapid expansion, we re looking for a talented Quality Assurance Development Specialist to join our team in Copenhagen.As our Quality Assurance ( QA ) Development Specialist, you will be responsible for global Quality Compliance alignment, training, quality checks and supporting agents across multiple offices. You will work closely together and report to the Global Director of Q C Operations as well as having a close relationship with the global Q C teams. Your tasks will be as follows: Tasks: Quality Assurance audits on Q C Agents, ensuring managers get feedback to provide to agents and increase global alignment Ensure Q C teams are aligned globally through providing regular workshops, test alignment through quarterly quizzes, etc. Provide management with quality assurance reports, to identify gaps in alignment across teams and identify ways to resolve gaps and improve the quality of the agents work. Train and mentor new Q C agents and carry out ad-hoc training of the Trustpilot organisation regarding our work to ensure the integrity of our platform. Responsible for knowledge management in Q C, including our internal knowledge library, Google Team Drive, document standardization, etc. Responsible for creating processes and making changes for Q C Operations and Enforcement teams. Create User Guides to assist agents on using the vast number of tools available to the teams Work with the Q C Content Creator in order to update macros and support articles that accurately reflect Q C processes. Work closely with our TnT (Tech) Team in order to fix any bugs and propose changes to ensure efficient processes. Reporting and working closely with product teams from different departments on specific projects that have an impact on the Q C, ensuring Q C concerns are identified and raised. Back-up other QA team member on Zendesk administration, which includes setting up dashboards statistical overview, maintaining Zendesk tags topics triggers based on current processes, upload macros for agent use, constantly research Zendesk updates that can benefit operations, etc. Skills: Minimum of 2 year of experience working with Quality Assurance or similar. Great understanding of Quality Assurance and Quality Improvement processes. Experience working with and or developing processes. Previous experiences in the Compliance sector. Excellent presentation skills and experience in creating reports. Able to work independently and manage multiple projects at once. A proactive approach to task and issue handling is essential. Ability to deal with multiple stakeholders on a regular basis. Solid organisational skills and a keen eye for details. Excellent written communication skills in English. Knowledge of other foreign languages is a plus. Ability to structure your work and deliver results. A can-do person who works efficiently takes pride in ensuring quality alignment across multiple teams. Application Interested in learning more about Trustpilot? Check out our website www.trustpilot.com or stop by The Muse. If you see yourself in this role, submit your application in English by clicking below, and make sure to upload a personalised cover letter, in which you describe why you would be our ideal Quality Assurance Development Specialist. Trustpilot is a global company and our data practices are designed to ensure that your personally identifiable information is appropriately protected. Please note that your personal information will be transferred, accessed and stored globally as necessary for the uses and disclosures stated in ourPrivacy Policy. About TrustpilotTrustpilot is a global, online review community that builds trust and increases transparency between consumers and businesses. Currently boasting more than 50 million consumer reviews of 250,000 businesses, Trustpilot produces a TrustScore for businesses based on recent reviews. Trustpilot s community is live in 25 countries and more than 10,000 consumers sign up to Trustpilot every day. The platform also helps businesses generate insights through customer review data analytics. This can be used to continuously improve business operations, increase customer satisfaction and drive innovation. By enabling businesses to engage directly with customers, Trustpilot aims to set new global standards in consumer to business dialogue. Trustpilot has customers in 65 countries and has developed strong positions in Denmark, Sweden, UK, France, Germany and the Netherlands, as well as the US. With offices in Copenhagen, London, New York, Denver, Berlin, Melbourne and Vilnius Trustpilot s 700 employees represent 40 different nationalities.11jobnetdc9e0567100000000000aDK_OFIR_02DKDanmark228DKK2019-07-17T00:00:000000https://business.trustpilot.com/jobs/17008150EuropaDanmarkSjælland & øerStorkøbenhavnKøbenhavn3536665TRUSTPILOT A/S11Pilestræde 58, 51112København KDKDanmark0DKDanmarkDKDanmark8Fuldtid46Permanent769135JobNet4996649499664910028-05-20190https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=dc9e0567https://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=dc9e0567https://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=dc9e0567&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=dc9e0567&page=EmailApplyForm&component=SendApplicationButton1Dansk3Læse/ tale315218Kvalitetsmedarbejder0Øvrige361937562noreply@ofir.comDKDanmarkDKDanmark330044826QA Specialist for Supplier Quality ManagementRobot Description We are growing and changing. So are our needs for supply. Be a dedicated QA specialist and use your experience to help us revise and implement new QMS procedures for an even better Supplier Quality Management, SQM. You will join the QA specialist team within Supplier Quality Management in Brønshøj and take part in our mission to ensure product supplies fulfil RMED specifications and quality requirements. Perform QA within SQM and develop new QA initiatives Collaborating with Global Procurement team, production, R D and many other functions in the organisation, you secure high quality and reliable products from our suppliers placed worldwide. Your mission is not only to perform QA on current suppliers, but also to partake in new supplier selection, approval, implementation and maintenance. To achieve this, you: Plan and conduct system audit of the Quality Management System and process audit of the production at the current and new suppliers in accordance with ISO 13485:2016 and MDSAP Classify suppliers to ensure right focus depending on risks, challenges and opportunities If required pre-approval of new supplier in form of e.g. a supplier visits Implement and approve Quality Agreements Follow-up on quality matters with suppliers Participate in develop new QA procedures within SQM together with the team and involved departments. The SQM area is under updating and there are great possibilities to contribute in optimizing the way of working and the QMS procedures QA supplier quality evaluation meetings Travel approximately 30-40 days per year to visit suppliers and perform audits The supplier portfolio is broad and are within outsourced processes, outsourced services, contract manufactures and critical suppliers. We offer you A unique opportunity to work in the field of medical technology, where knowledge sharing and professionalism combine to make it both fun and meaningful to go to work. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people s lives. We offer you freedom with responsibility , opportunities for training and career development, and a wide range of staff benefits. Application deadlineApplication deadline is Thursday 3 July, 2019. Start the application process by pressing Apply Online and follow the guidelines on our corporate career site. Please attach your CV and other relevant documents. We look forward to receiving your application. For further information, please contact Senior Recruiter, Peter Høgh, 45 61 79 55 64 or QA Specialist Liselotte Siim at 45 30 11 90 48. Qualifications Experienced QA specialist with knowledge of production and R D Passionate about quality and highly independent in your work, you are ready to take on own responsibility and make decisions that may influence the final product and potentially the lives of consumers worldwide. You also: Possess 5 years of experience with QA, reliability and SQM in the Medical Device, IVD, pharma or similar regulated industries preferably related to production, product quality and or R D Have an engineering or pharmaceutical degree Preferably, have knowledge of ISO 13485:2016, FDA QSR and MDSAP Speak and write English fluently Danaher Corporation OverviewDanaher is a global science technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked 162 on the Fortune 500 and our stock has outperformed the S P 500 by more than 5,200 over 25 years.At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive. Organization: Radiometer Job Function: Quality and Regulatory Affairs Primary Location: EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj Schedule: Full-time

Description

We are growing and changing. So are our needs for supply. Be a dedicated QA specialist and use your experience to help us revise and implement new QMS procedures for an even better Supplier Quality Management, SQM.

You will join the QA specialist team within Supplier Quality Management in Brønshøj and take part in our mission to ensure product supplies fulfil RMED specifications and quality requirements. 

Perform QA within SQM and develop new QA initiatives

Collaborating with Global Procurement team, production, R&D and many other functions in the organisation, you secure high quality and reliable products from our suppliers placed worldwide. Your mission is not only to perform QA on current suppliers, but also to partake in new supplier selection, approval, implementation and maintenance. To achieve this, you:

  • Plan and conduct system audit of the Quality Management System and process audit of the production at the current and new suppliers in accordance with ISO 13485:2016 and MDSAP 
  • Classify suppliers to ensure right focus depending on risks, challenges and opportunities
  • If required pre-approval of new supplier in form of e.g. a supplier visits
  • Implement and approve Quality Agreements
  • Follow-up on quality matters with suppliers 
  • Participate in develop new QA procedures within SQM together with the team and involved departments. The SQM area is under updating and there are great possibilities to contribute in optimizing the way of working and the QMS procedures
  • QA supplier quality evaluation meetings
  • Travel approximately 30-40 days per year to visit suppliers and perform audits


The supplier portfolio is broad and are within outsourced processes, outsourced services, contract manufactures and critical suppliers. 

We offer you

A unique opportunity to work in the field of medical technology, where knowledge sharing and professionalism combine to make it both fun and meaningful to go to work. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development, and a wide range of staff benefits.
Application deadlineApplication deadline is Thursday 3 July, 2019. Start the application process by pressing "Apply Online" and follow the guidelines on our corporate career site. Please attach your CV and other relevant documents. We look forward to receiving your application.
For further information, please contact Senior Recruiter, Peter Høgh, +45 61 79 55 64 or QA Specialist Liselotte Siim at + 45 30 11 90 48.
 

Qualifications 

Experienced QA specialist with knowledge of production and R&D

Passionate about quality and highly independent in your work, you are ready to take on own responsibility and make decisions that may influence the final product and potentially the lives of consumers worldwide. 
You also:

  • Possess 5+ years of experience with QA, reliability and SQM in the Medical Device, IVD, pharma or similar regulated industries – preferably related to production, product quality and/ or R&D
  • Have an engineering or pharmaceutical degree
  • Preferably, have knowledge of ISO 13485:2016, FDA QSR and MDSAP
  • Speak and write English fluently


Danaher Corporation

OverviewDanaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive. 

Organization:  Radiometer
Job Function:  Quality and Regulatory Affairs
Primary Location:  EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj
Schedule:  Full-time

RADIOMETER MEDICAL ApSBrønshøj2019-06-17T00:00:002019-07-03T00:00:00
330043248Senior Regulatory Professional in RA CMC BiopharmRobot The employees in Regulatory Affairs (RA) have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders simultaneously. Join a fast-changing environment where engaged people do their best every day to obtain and maintain clinical trial applications and market authorisations worldwide for all Novo Nordisk medicinal products across the globe. This makes RA a truly interesting place to work but also quite challenging. Are you up for this challenge in the near future? About the department The department RA Biopharm 2 is part of RABiopharm in Regulatory Affairs and is situated in the Novo Nordisk project house together with other regulatory affairs functions in Søborg. We are a group of highly skilled and dedicated people involved in every clinical and non-clinical aspects concerning marketed products as well as projects in development within Haemophilia and Growth Hormone disorders. The project portfolio is developing and in order to be able to handle the tasks and challenges within our area of responsibility we are looking for one more colleagues for the department. You will work with experienced and engaged colleagues and work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. In this dynamic environment, our dedicated group prepares worldwide regulatory strategies for submissions and is responsible for interactions with regulatory authorities. The position As Senior Regulatory Professional in RA Biopharm 2, you will be involved in a variety of regulatory tasks ensuring fast approval of our Clinical Trial Application (CTA s), marketing authorisation applications and variation applications in Life cycle Management (LCM). This means that you will compile, submit and maintain applications for our product portfolio. You will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions, ensuring high quality input to the regulatory strategies and submissions. In addition, you will plan, coordinate and review regulatory documentation, chair internal working groups and be our primary RA point of contact for relevant stakeholders within Novo Nordisk. Qualifications You hold a scientific Master s degree within Chemistry, Pharmacy, Engineering or similar, and you have at least 3-5 years of regulatory experience combined with solid analytical skills and knowledge from the pharmaceutical industry or a medicinal agency. Furthermore, you have experience with either CTA applications, marketing authorisation applications or variation applications including labelling. On a personal level, you demonstrate that you are organised, detail-oriented, a proactive problem solver and you enjoy working in a team and project oriented organisation. You communicate well and are completely comfortable speaking and writing in English and preferably also in Danish. In addition, you thrive in busy and changing circumstances and bring a can-do attitude and a healthy sense of humour. You keep focus on jointly moving the projects and are able to work independently, be challenged and find new solutions. Working at Novo Nordisk At Novo Nordisk we strive for excellence. As a world leader in diabetes care and a major player in haemostasis and hormone replacement therapy, we are proud to make a difference for millions of people around the world. We know that results are made together, and that great opportunities for personal and professional growth are important to provide. Contact For further information, please contact Henriette Sølver Schou 45 30751807 or Jane Møll Pedersen 45 30753759 Deadline 30 June 2019, however applications will be read on an on-going basis. 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.

The employees in Regulatory Affairs (RA) have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders simultaneously. Join a fast-changing environment where engaged people do their best every day to obtain and maintain clinical trial applications and market authorisations worldwide for all Novo Nordisk medicinal products across the globe. This makes RA a truly interesting place to work – but also quite challenging. Are you up for this challenge in the near future?

About the department
The department “RA Biopharm 2” is part of RABiopharm in Regulatory Affairs and is situated in the Novo Nordisk project house together with other regulatory affairs functions in Søborg. We are a group of highly skilled and dedicated people involved in every clinical and non-clinical aspects concerning marketed products as well as projects in development within Haemophilia and Growth Hormone disorders. The project portfolio is developing and in order to be able to handle the tasks and challenges within our area of responsibility we are looking for one more colleagues for the department.

You will work with experienced and engaged colleagues and work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. In this dynamic environment, our dedicated group prepares worldwide regulatory strategies for submissions and is responsible for interactions with regulatory authorities.

The position
As Senior Regulatory Professional in RA Biopharm 2, you will be involved in a variety of regulatory tasks ensuring fast approval of our Clinical Trial Application (CTA’s), marketing authorisation applications and variation applications in Life cycle Management (LCM). This means that you will compile, submit and maintain applications for our product portfolio. You will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions, ensuring high quality input to the regulatory strategies and submissions.

In addition, you will plan, coordinate and review regulatory documentation, chair internal working groups and be our primary RA point of contact for relevant stakeholders within Novo Nordisk.

Qualifications
You hold a scientific Master’s degree within Chemistry, Pharmacy, Engineering or similar, and you have at least 3-5 years of regulatory experience combined with solid analytical skills and knowledge from the pharmaceutical industry or a medicinal agency. Furthermore, you have experience with either CTA applications, marketing authorisation applications or variation applications including labelling.
 
On a personal level, you demonstrate that you are organised, detail-oriented, a proactive problem solver and you enjoy working in a team and project oriented organisation. You communicate well and are completely comfortable speaking and writing in English and preferably also in Danish. In addition, you thrive in busy and changing circumstances and bring a can-do attitude and a healthy sense of humour. You keep focus on jointly moving the projects and are able to work independently, be challenged and find new solutions.

 

Working at Novo Nordisk
At Novo Nordisk we strive for excellence. As a world leader in diabetes care and a major player in haemostasis and hormone replacement therapy, we are proud to make a difference for millions of people around the world. We know that results are made together, and that great opportunities for personal and professional growth are important to provide.

 

Contact
For further information, please contact Henriette Sølver Schou +45 30751807 or Jane Møll Pedersen + 45 30753759 
 

Deadline

30 June 2019, however applications will be read on an on-going basis. 

 

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/SSøborg2019-06-15T00:00:002019-06-30T00:00:00
330039590Servicekontrollant tilsyn af processer/procedurer - natRobot Servicekontrollant tilsyn af processer procedurer nat Er du servicemindet, selvstændig og udadvendt? Kan du tale Engelsk og Dansk? Så er du måske vores nye servicekontrollant. Til vores Serviceteam på Sjælland, hvor arbejdsopgaverne er afvekslende og ikke 2 dage er ens, søger vi nye kollegaer til fuldtidsstillinger. Vi søger en servicekontrollant der kan indgå i vores serviceteam du arbejder om natten du bidrage med at tilsikrer overholdelse af vores processer procedurer. Du vil indgå i driftens team af servicekontrollanter, der sammen skal medvirke til at opretholde et højt service - og kvalitetsniveau hos vores omdelere på Sjælland. Dine primære arbejdsopgaver: Supervision sikring af grænseflader Kontrol af at processer procedure overholdes Personeftersyn og eftersyn af produkter Din opgave har en stor præventiv effekt og det er derfor vigtigt, at du er yderst årvågen og er i god fysisk form. Du skal kunne lide at arbejde selvstændigt om natten og du yder altid en god service, teknisk flair, pc-kendskab skader ikke du skal hurtigt kunne opnå en god forståelse for de interne processer og procedurer. Vi forestiller os en rolig, selvstændig og moden person med naturlig autoritet. Det er helt afgørende at du udviser en sympatisk og rolig adfærd, og at du kan bevare roen når tingene går stærkt. Har du erfaring fra lignende job eller omdeling og distribution så er det en klar fordel, men ikke et krav. Vi tilbyder: Et afvekslende og selvstændigt job, hvor ikke to dage er ens - kompetente og engagerede kolleger med god teamånd og humoristisk omgangstone - et grundigt oplæringsforløb

Servicekontrollant tilsyn af processer/procedurer – nat

Er du servicemindet, selvstændig og udadvendt? Kan du tale Engelsk og Dansk? Så er du måske vores nye servicekontrollant.

Til vores Serviceteam på Sjælland, hvor arbejdsopgaverne er afvekslende og ikke 2 dage er ens, søger vi nye kollegaer til fuldtidsstillinger. Vi søger en servicekontrollant der kan indgå i vores serviceteam – du arbejder om natten – du bidrage med at tilsikrer overholdelse af vores processer/procedurer.

Du vil indgå i driftens team af servicekontrollanter, der sammen skal medvirke til at opretholde et højt service - og kvalitetsniveau hos vores omdelere på Sjælland.

 

Dine primære arbejdsopgaver:

  • Supervision/sikring af grænseflader
  • Kontrol af at processer/procedure overholdes
  • Personeftersyn og eftersyn af produkter

Din opgave har en stor præventiv effekt og det er derfor vigtigt, at du er yderst årvågen og er i god fysisk form.

Du skal kunne lide at arbejde selvstændigt om natten og du yder altid en god service, teknisk flair, pc-kendskab skader ikke – du skal hurtigt kunne opnå en god forståelse for de interne processer og procedurer.

Vi forestiller os en rolig, selvstændig og moden person med naturlig autoritet. Det er helt afgørende at du udviser en sympatisk og rolig adfærd, og at du kan bevare roen når tingene går stærkt.

Har du erfaring fra lignende job eller omdeling og distribution så er det en klar fordel, men ikke et krav.

Vi tilbyder:

Et afvekslende og selvstændigt job, hvor ikke to dage er ens - kompetente og engagerede kolleger med god teamånd og humoristisk omgangstone - et grundigt oplæringsforløb

 

 

A/S BLADKOMPAGNIETRødovre2019-06-11T00:00:002019-07-01T00:00:00
da-DK

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