LSC has a fantastic contract opportunity for QA Engineer to join the QA Engineering group ii advanced global team in Denmark on that promotes self-development, encourages collaboration, and fosters a learning environment. The company specializes 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:
- Actions related to FAT prerequisites e.g. ensure that Change Management Records (CMR) are in execute, perform GDP training of Vendor's testing personnel etc.
- Review and approval validation documentation (protocols, design specifications RTM etc.)
- Participate in Quality Risk Management processes - Review of test documentation (FAT/SAT/IQ/ OQ/PQ) including deviations found during testing -
- Supervision of vendors/contractors during relevant validation activities to ensure correct level of quality -
- Turnover package reviews, both from vendor and contractor.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum 5 years proven experience and knowledge within the following areas:
- QA approval of qualification documents and SOPs
- Experience with projects and working in or around operating facilities
- Working knowledge of principles, concepts and practices of ASTM E2500 / Leveraging Verification process, CFR 21 Part 11 and EU GMP Annex 11 Knowledge of regulatory requirements for aseptic processes and validation (EU GMP Annex 1 and Annex 15)
- CAPA, Deviation and Change Control handling
- QA approvals in Computerized Maintenance Management System *
Apply via this advert or contact Sarah Ninan at +353 214771329 if you have any more questions about this opportunity!