Senior QA Specialist for Cell and Gene Therapy
4 weken geleden
We are Galapagos, a dynamic and growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.
We're in the business of changing lives. Our Cell & Gene Therapy organization in Leiden/NL is seeking a highly motivated QA PoC and Central Site Coordinator (Sr. Specialist) to support our QA team in setting up, promoting and maintaining the QA model in our dynamic business environment.
The successful candidate will report to the QA Manufacturing Operations Lead, in the IMP QA Oncology team based in our Central EU site in Leiden, NL.
Key Responsibilities:
- Manage QM attributes for PoC and Central Site activities: Deviations, CAPAs, Change Controls and Complaints
- QA batch record review
- Support materials release and support batch release process
- Support equipment management at our PoC locations
- Provide QA support to the materials kitting process
At Galapagos, we believe in the power of collaboration to achieve our ambitious goals. Our workflow is dynamic, fast and varied, and we're looking for a team player who can thrive in this environment.
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