Job Overview
The QA Manufacturing Specialist plays a pivotal role in ensuring the quality of work meets internal and external cGxP requirements.
Key Responsibilities
* Ensure adherence to GMP, EU Annex 1, FDA, and other applicable regulatory guidelines to maintain operational excellence.
* Perform daily facility audits and walk-throughs, encompassing Grade A, B, C, and D areas, to guarantee GMP compliance.
* Conduct routine observations of batch-related critical activities within manufacturing processes, upholding defined procedures and batch records.
Core Deliverables
* Support cross-functional readiness for batch certification, ensuring timely completion of all documentation.
* Collaborate with the manufacturing team to implement in-process control (IPC) and end-of-batch reconciliation processes, ensuring batch-related operations align with defined procedures and batch records.