Advanced Quality Assurance Expert

4 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

About the Role

We are seeking a highly motivated Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S. The successful candidate will support CMC API Development within the raw material and CMO shipping area.

Key Responsibilities

  • Deliver best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and drug product production for clinical trials.
  • Challenge and approve documents in connection with raw materials and CMO shipping.
  • Participate in regulatory inspections and audits and ensure compliance with cGMP and other regulatory requirements.
  • Secure quality agreements with external suppliers.

About You

To succeed in this role, you have:

  • MSc in Pharmaceutical Sciences, Engineering, Biochemistry, or similar.
  • At least 1 year of experience from the pharmaceutical industry within quality or production.
  • Experience with GMP.
  • Experience working with raw materials for API production.
  • Proficiency in English.
  • Proficiency in Danish is an advantage, but not a requirement.

About the Department

CMC API QA is a department that employs 35 skilled and motivated colleagues in four teams, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials, and the release of API for clinical trials.

What We Offer

We value teamwork, diversity, and humor very high, and we will make sure you, as a new employee, feel welcome and integrated. Further, a thorough individual training plan will be made together with your mentor.

Contact

For further information, please contact Associate Manager Caroline Benedicte Kjærulff Mathiesen at Novo Nordisk A/S.



  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S. The successful candidate will support CMC API Development within the raw material and CMO shipping area.Key ResponsibilitiesEnsure compliance with regulatory requirements, quality standards, and company...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Customer Service Quality Assurance Expert to join our team at Novo Nordisk A/S in Søborg, Denmark.Job OverviewThis is a unique opportunity to shape the future of Customer Service in Novo Nordisk for the benefit of our patients across the world. As a Customer Service Quality Assurance Expert, you will work with...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Expert to join our team at Novo Nordisk A/S. As a QA Specialist, you will play a crucial role in ensuring patient safety and delivering high-quality standards for our products and production processes.This is an exciting opportunity to work in a fast-paced environment with a strong focus on...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team as a QP delegate, primarily responsible for releasing internal and externally produced API for usage in the Novo Nordisk clinical trial pipeline.Key Responsibilities:Ensuring best-in-class quality assurance of our API for clinical...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the Role: We are seeking a highly motivated and experienced QA Scientist to join our team at AGC Biologics. As a key member of our Quality Assurance department, you will play a vital role in ensuring the quality and compliance of our manufacturing processes and facilities.Key Responsibilities: As a QA Scientist, you will be responsible for:Reviewing...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About UsAGC Biologics is a leading Contract Development and Manufacturing Organization dedicated to bringing new biopharmaceuticals to market.We strive to improve life quality by delivering dynamic solutions, technologies, and customized services for protein-based therapeutics and cell and gene therapies.Job DescriptionAs a QA Scientist, you will be a vital...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance (QA) Scientist to join our team at AGC Biologics. As a QA Scientist, you will play a crucial role in ensuring the quality of our products and processes, adhering to Good Manufacturing Practice (GMP) standards.Key ResponsibilitiesOversee the quality assurance review and...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled and experienced Quality Assurance Professional to join our team at Novo Nordisk. As a Customer Service Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our customer service processes.Key ResponsibilitiesProvide quality assurance input on designing and...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    OverviewNovo Nordisk A/S is a dynamic and innovative company that is passionate about delivering exceptional quality in the pharmaceutical industry.SalaryWe offer a competitive salary of approximately €60,000 - €80,000 per year, depending on experience.Job DescriptionAs a QA Professional, you will play a crucial role in ensuring the high-quality...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleWe are seeking an experienced Lead Quality Assurance Manager to join our team at AGC Biologics. As a key member of our quality assurance department, you will be responsible for leading a team of dedicated professionals in ensuring the highest quality standards in our pharmaceutical development processes.The successful candidate will have a...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Quality Assurance Specialist Opportunity at AGC BiologicsWe are seeking a highly skilled Quality Assurance Specialist to join our Quality Systems team in Copenhagen, Denmark.Key Responsibilities:Collaborate with partners to optimize GMP Training standards and systems.Develop new training standards, courses, and programs to support business needs and...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    We are seeking a highly motivated and experienced Quality Assurance Professional to join our Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA team at Novo Nordisk A/S.The successful candidate will support CMC API Development within the raw material and Contract Manufacturer (CMO) shipping area. This role is responsible...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled IT Quality Assurance Specialist to join our team at Novo Nordisk A/S. As a key member of our Quality Control team, you will be responsible for ensuring the highest level of quality and compliance in our laboratory equipment.Key ResponsibilitiesDevelop and execute test plans and protocols for laboratory equipment...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the Job:We are seeking a highly skilled Quality Assurance and Validation Specialist to join our team at Novo Nordisk A/S.Key Responsibilities:Set the quality direction for the capacity expansion projectDeliver best-in-class quality for qualification of equipment/facilities and IT-systemsHandle larger and complex quality issuesEnsure a LEAN culture and...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Quality Assurance Specialist RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk A/S in Bagsværd, Denmark.About the RoleThis is an exciting opportunity to work in a dynamic and professional environment where you will play a crucial role in ensuring the quality and safety of products for clinical trials.You will...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleWe are seeking a highly skilled Compliance Quality Assurance Specialist to join our Plant Engineering team. In this role, you will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in our facilities.Key ResponsibilitiesCollaborate with colleagues to maintain compliance and quality...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleThe Digital Health & Staffs Quality department at Novo Nordisk A/S is seeking a highly skilled Customer Service QA Professional to join their team. As a key member of the department, you will be responsible for ensuring the quality and compliance of Customer Service processes across the organization.Main ResponsibilitiesAs a Customer Service QA...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our CMC API QA team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our CMC API facilities and equipment.Key ResponsibilitiesDevelop and implement quality strategies to ensure compliance with regulatory requirementsConduct...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleWe are seeking a highly skilled and experienced Quality Assurance Specialist to join our Quality Systems department. As a GMP Trainer, you will play a crucial role in enhancing our training standards to improve quality across the company.Key ResponsibilitiesCollaborate with partners to drive improvement projects optimizing our GMP Training...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job SummaryAGC Biologics is seeking an experienced QA Scientist to join our team in Copenhagen. The successful candidate will be responsible for supporting Supply Chain, Process Transfer, and QC for late-stage and commercial products.Key ResponsibilitiesClose collaboration with internal stakeholdersChange control, deviation handling, and CAPAsReview and...