Quality Assurance Specialist
Vor 5 Tagen
We are seeking a Quality Assurance Specialist to join our team at WuXi AppTec. In this role, you will play a critical part in ensuring the quality and compliance of our products.
Job DescriptionThis position is responsible for providing quality assurance support primarily with the review of bulk or packaged commercial drug products, raw material batches if required, and maintaining working relationships with QA departments at contract facilities.
The position will support on-the-floor QA activities (deviation, CAPA, OOS, change control, batch release, archiving, complaints) at the Couvet site, including work in 2*8 shift if required.
As a member of the Quality Operations team, this position will be expected to be a reliable source of information and interpretation of quality and cGMP compliance requirements.
The position holder is responsible and accountable for the tasks given below.
- Supports the design of Master Batch Records for bulk or packaged commercial drug products.
- Is responsible for the review "on the floor" (if applicable) of executed batch records and associated QA samples (API, raw materials, bulk, semi-finished and finished products).
- Ensures compilation and archiving of documentation for compliance to GMP as appropriate.
- Handles deviations, complaints, and CAPA related to Couvet site and ensures the execution/follow-up of escalation processes.
- Handles GMP activities in cooperation with partners.
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