Description

Take complete responsibility for API manufacturing operations during the assigned shift. Execute production batches as per approved BMRs, SOPs, and validated process parameters. Monitor and control critical process parameters such as: Temperature Pressure Vacuum pH Agitation Addition rate Reaction time Drying parameters Supervise operations including charging, reaction, heating/cooling, extraction, filtration, centrifugation, distillation, solvent recovery, drying, milling, and packing, as applicable. Ensure batches are completed within the approved cycle time and production schedule. Monitor batch yield, process losses, solvent consumption, and productivity. Identify abnormal process conditions and take appropriate corrective action in consultation with the Production Manager/QA. Lead and supervise Production Executives, Officers, Operators, and contract manpower during the shift. Allocate manpower according to batch and operational requirements. Ensure adequate manpower availability for critical operations. Monitor operator performance and ensure adherence to SOPs and safety procedures. Train and guide operators on manufacturing procedures, GMP, documentation, and safety. Ensure all manufacturing activities are performed in compliance with cGMP, SOPs, BMRs, GDP, and data-integrity requirements. Review and ensure proper completion of BMRs, equipment logbooks,



cleaning records, and shift records. Ensure proper line clearance, equipment status labeling, area clearance, and cleaning verification. Report and support investigation of: Deviations Process abnormalities Yield variations Equipment failures Batch failures Support OOS/OOT, deviation, CAPA, change-control, and investigation activities wherever applicable. Coordinate with QA/QC for sampling, testing, line clearance, process checks, and batch-related activities. Coordinate with Engineering/Maintenance for equipment breakdowns and technical problems. Coordinate with Warehouse for raw materials, solvents, and packing materials. Coordinate with EHS for safety-related activities and emergency situations. Ensure effective communication with the incoming/outgoing shift regarding batch status, equipment condition, pending activities, and abnormalities. Supervise operation of API manufacturing equipment such as: Reactors Centrifuges Nutsche filters / Filter dryers ANFD Vacuum/agitated dryers Distillation systems Solvent recovery systems Milling and sieving equipment Identify equipment abnormalities and coordinate with Engineering for timely resolution. Monitor equipment utilization and minimize production downtime. Ensure equipment is properly cleaned, labeled, and released before use.

📌 Assistant Manager (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar