Description

To execute, monitor, and coordinate API manufacturing activities in accordance with approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), cGMP guidelines, and EHS requirements to achieve production targets, maintain product quality, and ensure secure and compliant manufacturing operations. 2. Key Responsibilities A. Production Operations Execute and supervise day-to-day API manufacturing activities as per the approved production schedule. Perform manufacturing operations such as raw material charging, chemical reactions, distillation, extraction, filtration, centrifugation, drying, milling, and packing, as applicable. Monitor critical process parameters, including temperature, pressure, pH, agitation, vacuum, and reaction time. Ensure compliance with approved process parameters and manufacturing instructions. Monitor batch progress, yield, cycle time, and material consumption. 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 Follow current Good Manufacturing Practices (cGMP), SOPs, and data integrity requirements. Complete BMRs, equipment logbooks, cleaning records, and production reports accurately and contemporaneously. Ensure proper line clearance, equipment cleaning, and material status labeling before manufacturing activities. Maintain traceability of raw materials, intermediates, and finished products. Support deviation investigations, root cause analysis, and CAPA implementation. Maintain production documentation in an audit-ready condition. C. Process Monitoring and Improvement Monitor batch yield, cycle time, solvent consumption, and process losses. Assist in troubleshooting manufacturing issues and identifying process bottlenecks. Support process optimization, validation, cleaning validation, and technology transfer activities. Implement approved process improvements to enhance productivity and reduce wastage.



Ensure that process changes are carried out only through approved change-control procedures. D. Equipment and Maintenance Ensure readiness and cleanliness of production equipment before batch initiation. Operate and monitor reactors, centrifuges, dryers, filters, pumps, and other process equipment as authorized. Coordinate with engineering and maintenance teams for preventive maintenance and breakdown resolution. Ensure proper equipment status labeling, usage records, and logbook entries. Verify compliance with applicable equipment qualification and calibration requirements. E. Safety and Environmental Compliance Follow EHS procedures, PPE requirements, and approved chemical-handling practices. Ensure safe handling of solvents, acids, alkalis, and other hazardous materials. Follow permit-to-work requirements and applicable process safety precautions. Report unsafe conditions, near misses, and incidents promptly. Ensure proper waste handling, solvent recovery, and housekeeping practices. F. Team Coordination Guide production operators and junior personnel during manufacturing activities. Allocate routine tasks and monitor execution during assigned shifts. Train team members on SOPs, GMP, equipment operation, and safety procedures. Coordinate with QA, QC, stores, engineering, maintenance, and utility departments. Ensure effective shift handover and communication of batch status and pending activities. G. Reporting and Performance Monitoring Prepare daily production reports and update batch status. Monitor production targets, batch yield, cycle time, and equipment downtime. Report deviations from production plans and recommend corrective actions. 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, as per company requirements. 4. Experience Typically 3–6 years of experience in API manufacturing. Hands-on experience in chemical synthesis, batch processing, and production documentation.

📌 Senior Officer (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar