Quality Assurance Officer
- CGMP Compliance on the Shop Floor.
- Review of BMR and BPR, With Equipment Printouts.
- Point out non-compliance of line with observation.
- Team handling for planning and execution for preparation and review of APQR and batch data entry for APQR (regulated market).
- Provide necessary direct and indirect support for presenting required documents during internal or external audits.
- Issuance of various documents from different departments as per issuance requests in a timely manner, and properly organize all documents in the Document Cell.
- Issuance, retrieval, distribution, and archival of quality documents; preparation, review, issuance, and revision of SOPs.
- Responsible for the issuance of the Batch Manufacturing Record and the Batch Packaging Record.