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.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- 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
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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!