Description:
- Shop-Floor QA / GMP Compliance Perform routine QA oversight of API manufacturing and packaging operations. Ensure manufacturing activities are performed according to approved SOPs, BMR/BPR, specifications, and GMP requirements. Conduct line clearance and area/equipment verification before commencement of manufacturing activities. Monitor critical manufacturing activities and ensure compliance with approved process parameters. Verify equipment status, cleaning status, calibration status, and area conditions. Ensure proper identification and status labeling of raw materials, intermediates, solvents, finished products, and equipment. Raise and document GMP observations and ensure timely corrective actions. 2. Batch Documentation & Review Review Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), equipment logbooks, and associated GMP documents. Ensure entries are complete, accurate, traceable, and contemporaneous. Review manufacturing yields, reconciliation, process parameters, IPC results, and deviations.



Ensure batch documentation is completed and reviewed within the defined timelines. Support batch disposition/release activities in coordination with QA management. 3. Deviation, Investigation & CAPA Initiate, review, and support investigation of deviations, incidents, OOS/OOT, process failures, and market complaints, as applicable. Participate in root-cause analysis using appropriate investigation tools. Prepare and monitor CAPA plans and verify effectiveness. Ensure investigations are scientifically sound, properly documented, and completed within timelines. 4. Change Control Review and assess change controls related to manufacturing processes, equipment, facilities, materials, analytical methods, documents, and utilities. Coordinate with Production, QC, Engineering, Regulatory Affairs, and other functions for impact assessment. Monitor implementation of approved changes and ensure required documentation is completed. 5. SOP & Quality Sy

📌 Senior Executive (Mumbai)
🏢 Cadila Pharmaceuticals
📍 Mumbai