Monitor shop floor activities to ensure compliance with cGMP, SOPs, approved Batch Manufacturing Records (BMR), and regulatory requirements. Review Batch Manufacturing Records (BMR), logbooks, equipment records, and GMP documentation for accuracy and completeness. Perform line clearance, area clearance, equipment clearance, and in-process verification before and during manufacturing activities. Review and investigate deviations, incidents, OOS, OOT, market complaints, and implement effective CAPA. Coordinate Change Control, Quality Risk Management (QRM), and quality improvement initiatives. Support process validation, cleaning validation, equipment qualification, and utility qualification activities. Review and approve SOPs, protocols, reports, specifications, and validation documents. Ensure compliance with Data Integrity (ALCOA+), Good Documentation Practices (GDP), and electronic record requirements. Conduct internal GMP audits, self-inspections, and support customer and regulatory inspections (USFDA, MHRA, EU GMP, WHO GMP, TGA). Monitor environmental conditions and GMP compliance across production and warehouse areas. Coordinate with Production, QC, Engineering, Warehouse, and EHS to resolve quality and compliance issues. Mentor and guide QA Officers and junior team members on GMP and quality systems. Maintain QA metrics, compliance reports, and trend analysis for management review.
