To execute and monitor API manufacturing activities as per approved Batch Manufacturing Records (BMRs), SOPs, cGMP guidelines, and safety procedures, ensuring product quality, production targets, batch yield, and timely completion of manufacturing operations. 2.

Key Responsibilities
A. Production Operations Execute batch manufacturing activities as per approved BMRs and production schedules. Supervise day-to-day operations such as raw material charging, chemical reactions, distillation, extraction, filtration, centrifugation, drying, milling, and packing. Monitor process parameters such as temperature, pressure, pH, agitation, reaction time, and vacuum. Ensure proper handling, identification, and traceability of raw materials, intermediates, and finished products. Coordinate with production supervisors and operators to achieve daily production targets. Monitor batch progress and report abnormalities to the reporting manager. B. GMP and Documentation Follow cGMP requirements, SOPs, safety instructions, and data integrity practices. Maintain accurate and timely entries in BMRs, equipment logbooks, and cleaning records. Ensure line clearance, equipment status labeling, and cleaning verification before starting operations. Report deviations, process abnormalities, and incidents promptly. Support deviation investigations, CAPA implementation, and audit readiness. Ensure compliance with applicable regulatory and company requirements. C. Process Monitoring and Yield Improvement Monitor batch yield, cycle time, solvent consumption, and material utilization. Identify process variations and communicate them to the production manager.



Assist in troubleshooting manufacturing problems and minimizing process losses. Support process validation, technology transfer, and process improvement activities. Ensure proper recovery and reuse of solvents wherever approved procedures permit. D. Equipment and Maintenance Ensure equipment readiness before batch initiation. Monitor the operation of reactors, centrifuges, dryers, filters, pumps, and other manufacturing equipment. Coordinate with engineering and maintenance teams for equipment breakdowns. Follow preventive maintenance, calibration, and equipment cleaning requirements. Ensure proper equipment status identification and logbook maintenance. E. Safety and Environmental Compliance Follow EHS guidelines and ensure appropriate PPE usage. Handle chemicals, solvents, and hazardous materials according to approved procedures. Follow permit-to-work requirements and established safety precautions. Report unsafe conditions, near misses, and incidents to the concerned department. Follow waste disposal, solvent handling, and environmental protection procedures. F. Team Coordination Guide operators and production personnel during routine manufacturing activities. Allocate and monitor assigned tasks during shifts. Train operators on SOPs, GMP, equipment operation, and safety practices. Coordinate with QA, QC, stores, engineering, and utility departments. Support shift handovers and communicate batch status, pending activities, and equipment issues. 3. Qualification B.
Sc./M.
Sc. in Chemistry or B.
E./B.
Tech in Chemical Engineering. Relevant qualification in chemistry or chemical process operations as per company requirements. 4. Experience Typically 4–8 years of experience in API manufacturing.

📌 Senior Officer (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar