Description

To execute and monitor API manufacturing operations in accordance with approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), cGMP requirements, and EHS guidelines to achieve production targets while ensuring product quality, process compliance, and workplace safety. 2. Key Responsibilities A. Production Operations Execute daily API manufacturing activities according to the approved production schedule. Supervise and monitor raw material charging, chemical reactions, distillation, extraction, filtration, centrifugation, drying, milling, and packing operations, as applicable. Monitor critical process parameters such as temperature, pressure, pH, agitation, vacuum, and reaction time. Ensure adherence to approved BMRs and established process parameters. Monitor batch progress, production output, yield, and cycle time. Coordinate with operators and production personnel to achieve daily production targets. Report process abnormalities, equipment breakdowns, and deviations to the reporting manager. B. GMP and Documentation Ensure compliance with cGMP, SOPs, and data integrity requirements. Complete and verify BMRs, equipment logbooks, cleaning records, and production reports. Ensure proper line clearance, equipment cleaning, and material status labeling. Maintain material traceability and proper identification of raw materials and intermediates. Report deviations and support investigations, root cause analysis, and CAPA implementation. Maintain production records in an audit-ready condition. C. Process Monitoring and Yield Improvement Monitor batch yield, cycle time, solvent consumption, and material utilization. Identify process losses and support troubleshooting activities. Assist in process optimization, process validation, and technology transfer. Implement approved measures to improve productivity and reduce wastage. Monitor solvent recovery and ensure compliance with approved procedures.



D. Equipment and Maintenance Ensure production equipment is clean, operational, and ready for use. Monitor reactors, centrifuges, dryers, filters, pumps, and other manufacturing equipment. Coordinate with engineering and maintenance teams for breakdown resolution. Ensure equipment logbooks and usage records are maintained. Follow equipment qualification, calibration, and preventive maintenance requirements. E. Safety and Environmental Compliance Ensure compliance with EHS procedures and appropriate PPE requirements. Follow approved procedures for handling chemicals, solvents, acids, and alkalis. Ensure safe operation of manufacturing equipment and compliance with permit-to-work requirements. Report unsafe conditions, near misses, and incidents. Maintain positive housekeeping and follow waste disposal and environmental procedures. F. Team Coordination Guide production officers and operators in routine manufacturing activities. Allocate daily tasks and monitor execution during assigned shifts. Train team members on SOPs, GMP, equipment operation, and safety. Coordinate with QA, QC, stores, engineering, maintenance, and utility departments. Ensure effective shift handover and communication of batch status. G. Reporting and Monitoring Prepare daily production and batch status reports. Track production targets, yield, cycle time, and equipment downtime. Monitor consumption of raw materials and solvents. Support internal audits, customer audits, and regulatory inspections. Ensure timely completion of assigned documentation and corrective actions. 3. Educational Qualification B.Sc. / M.Sc. in Chemistry, or Diploma / B.E. / B.Tech in Chemical Engineering, according to company requirements. 4. Experience Typically 2–5 years of experience in API manufacturing. Practical knowledge of chemical synthesis, batch processing, and production documentation. Working knowledge of cGMP, BMRs, SOPs, deviations, CAPA, and EHS requirements.

📌 Executive (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar