Quality Assurance Specialist Job Summary
This role is part of a team within the Global Development Quality department, supporting GMP quality assurance activities for an IMP license. The successful candidate will provide quality support to production teams, ensuring cGMP standards are maintained.
Key Responsibilities:
* Provide timely reviews on batch documentation (EBRs) and line clearances.
* Assist in resolving concerns commensurate with risk.
* Liaise with other departments to promote improvements in GMP and quality standards.
* Conduct, report, and display metrics for continuous audit readiness and cGMP compliance.
The ideal candidate should have strong understanding of sterile manufacturing operations. They should be able to learn computerized systems for daily performance tasks.
The ability to prioritize tasks effectively manage multiple responsibilities under tight deadlines is essential.