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. 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. Ensure production records are complete, accurate, and available for QA review. 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. Support equipment qualification and process-validation activities as required.

📌 Assistant Manager (Dahej)
🏢 CPL Pharmaceuticals Private
📍 Dahej