Description

To supervise and coordinate API manufacturing operations, ensuring adherence to approved manufacturing procedures, cGMP requirements, safety standards, production schedules, and quality specifications. The role focuses on achieving production targets, optimizing batch yield, maintaining documentation compliance, and coordinating manpower and resources efficiently. 2. Key Responsibilities A. Production Planning and Execution Execute and monitor daily API manufacturing activities according to the production plan. Supervise manufacturing operations, including raw material charging, chemical reactions, distillation, extraction, filtration, centrifugation, drying, milling, and packing, as applicable. Monitor critical process parameters such as temperature, pressure, pH, vacuum, agitation, and reaction time. Ensure adherence to approved Batch Manufacturing Records (BMRs), SOPs, and established process parameters. Coordinate manpower, equipment, raw materials, and utilities to achieve production targets. Monitor batch progress, identify bottlenecks, and take corrective action within authorized procedures. Ensure timely batch completion and proper shift handover. B. GMP and Regulatory Compliance Ensure compliance with current Good Manufacturing Practices (cGMP), data integrity requirements, and applicable regulatory guidelines. Review production documentation for accuracy, completeness, and compliance. Ensure line clearance, equipment cleaning, material status labeling, and traceability. Report and support investigations of deviations, incidents, and process abnormalities.



Coordinate CAPA implementation and ensure timely completion of assigned actions. Support internal audits, customer audits, and regulatory inspections. C. Process Optimization and Yield Improvement Monitor batch yield, cycle time, solvent consumption, and material utilization. Analyze production losses and recommend measures to improve productivity. Support process troubleshooting, scale-up, technology transfer, and process validation activities. Identify opportunities to reduce solvent consumption, waste generation, and manufacturing costs. Ensure that process improvements and changes are implemented only through approved change-control procedures. D. Equipment and Maintenance Coordination Ensure equipment readiness and availability before batch initiation. Coordinate preventive maintenance and breakdown resolution with engineering. Ensure compliance with equipment qualification, calibration, and cleaning requirements. Monitor the performance of reactors, centrifuges, dryers, filters, pumps, and associated process equipment. Maintain equipment usage records and ensure proper status identification. E. Safety and Environmental Management Ensure compliance with EHS policies,



PPE requirements, and safe operating procedures. Monitor secure handling of chemicals, solvents, and hazardous materials. Ensure adherence to permit-to-work procedures and applicable process safety requirements. Report incidents, near misses, and unsafe conditions and support investigations. Promote solvent recovery, waste minimization, and environmental compliance. F. Team Leadership and Coordination Supervise production officers, junior executives, supervisors, and operators. Allocate manpower and monitor execution of assigned activities. Conduct on-the-job training related to GMP, SOPs, equipment operation, and safety. Coordinate with QA, QC, engineering, maintenance, stores, and utilities. Monitor team performance and ensure compliance with production and safety requirements. G. Documentation and Reporting Review BMRs, equipment logbooks, cleaning records, and production reports. Prepare daily, weekly, and monthly production performance reports. Track batch status, yield, cycle time, downtime, and production losses. Ensure timely closure of production documentation and assigned investigations. Maintain audit-ready documentation and effective shift communication. 3. Educational Qualification B.E. / B.Tech in Chemical Engineering, or M.Sc. in Chemistry or an equivalent relevant qualification. 4. Experience Typically 5–8 years of experience in API manufacturing. Experience in chemical synthesis, multi-step batch processing, and commercial-scale manufacturing.

📌 Senior Executive (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar