- Review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
- Perform line clearance and in-process checks.
- Ensure compliance with cGMP, GDP, and SOP requirements.
- Handle deviations, change control, CAPA, OOS, and OOT investigations.
- Prepare, review, and update SOPs and QA documents.
- Conduct GMP audits and shop floor inspections.
- Monitor documentation and maintain data integrity.
- Coordinate with Production, QC, Warehouse, and Engineering teams.
- Support internal, customer, and regulatory audits.
- Participate in process validation and cleaning validation activities.
- Review batch documents and support batch release.
- Conduct GMP training and maintain training records.