Review and approve batch manufacturing records (BMR), batch packaging records (BPR), logbooks, and analytical reports. Perform line clearance activities before and after manufacturing operations. Monitor and verify compliance with cGMP, GDP, data integrity, and SOP requirements across production and warehouse areas. Conduct in-process checks and shop floor monitoring to ensure adherence to approved procedures. Review and issue controlled documents, including SOPs, specifications, protocols, formats, and records. Participate in investigations related to deviations, incidents, out-of-specification (OOS), out-of-trend (OOT), change controls, and CAPAs. Support qualification and validation activities, including process validation, cleaning validation, equipment qualification, and method transfer. Review and maintain master documents, quality manuals, and site quality metrics. Coordinate sample management activities for validation and stability studies. Ensure timely completion of annual product quality reviews (APQR/PQR) and periodic quality reviews. Participate in internal audits, self-inspections, customer audits, and regulatory inspections. Monitor implementation and effectiveness of CAPAs arising from audits and investigations. Support training coordination and ensure compliance with training matrices. Ensure adherence to EHS guidelines and maintain audit readiness at all times.
