Quality Assurance Manager Role Denmark

Project QA (Downstream)

  • Posted Mar 8, 2023
  • Denmark
  • Contract
  • BBBH26228

LSC has a fantastic opportunity for Project QA (Downstream) to join an advanced global team in Denmark that promotes self-development, encourages collaboration, and fosters a learning environment. The company specialises in clinical & commercial manufacturing of Biotech medicines, including viral gene therapies and has built a strong reputation over the years for bringing complex and lifechanging therapies into reality. This is a chance for you to be a part of a fast-growing, multicultural company that has a compelling vision for shaping the future of medicine.


  • Support the initiation and closure of the direct impact equipment /systems change controls, CAPA and nonconformance. Ensure alignment with the project plans and approach with consideration given to ASTM E2500, towards testing for all Systems, from FAT-IOQ
  • Support vendor assessments as needed for impact equipment suppliers
  • Support the scope of all Equipment/System Qualification efforts with consideration of ASTM-E2500 Risk Assessment Approach and GAMP5 guidance
  • Support FAT execution at vendor site


  • Minimum of 5 to 7 years of experience implementing and supporting QA Commissioning, qualification and validation equipment scope and liaising with the CQV & Engineering teams on pharmaceutical Projects.
  • Experience as SME on Quality and Compliance issues
  • Working knowledge of ASTM E2500 / Leveraging Verification process
  • Working knowledge of GAMP 5
  • Available to support FAT protocol execution at vendor locations

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!

Apply via this advert or contact Pawel Jurkiewicz at +353 214771329 if you have any more questions about this opportunity!

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The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
  • 95% of LSC contracts are renewed letting you choose contracting as a long term career option
  • LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals!

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