Ensures manufacturing processes comply with GMP guidelines and SOPs. Reviews batch manufacturing records, analytical records, and deviation reports. Investigates Out of Specification (OOS) and Out of Trend (OOT) results. Prepares and reviews Corrective and Preventive Action (CAPA) reports. Conducts internal audits of manufacturing, QC, and support departments. Manages change control processes for manufacturing and quality systems. Reviews and approves product release documentation for finished goods. Coordinates with regulatory authorities during inspections and audits. Maintains quality management system documents and control procedures. Ensures environmental and personnel monitoring in cleanroom areas. Manages supplier qualification and vendor audit programs. Prepares annual product quality reviews (APQR) for all products. Stays updated with WHO-GMP, US-FDA, EU-GMP, and Schedule M guidelines.