Officer

To perform day-to-day API manufacturing activities according to approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), cGMP guidelines, and safety requirements to achieve production targets while maintaining product quality and process compliance. 2. Key Responsibilities A. API Manufacturing Operations Execute batch manufacturing activities as per approved BMRs and production schedules. Perform 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 correct identification and handling of raw materials, intermediates, and finished products. Monitor batch progress and report process abnormalities to the reporting manager. Ensure proper equipment cleaning, line clearance, and readiness before starting manufacturing operations. B. GMP and Documentation Follow cGMP requirements, SOPs, safety procedures, and data integrity practices. Complete BMRs, equipment logbooks, cleaning records, and other production documents accurately and contemporaneously. Ensure proper material labeling, status identification, and traceability. Report deviations, process variations, and incidents to the concerned supervisor. Support deviation investigations, CAPA implementation, and internal or external audits. Maintain good housekeeping and follow applicable documentation practices. C. Process Monitoring Monitor batch yield, process cycle time, solvent consumption, and material utilization. Ensure manufacturing parameters remain within approved process limits. Assist in troubleshooting routine production problems. Support process validation, cleaning validation, and technology transfer activities as assigned. Follow approved procedures for solvent recovery and waste minimization. D. Equipment Handling Operate reactors, centrifuges, dryers, filters, pumps, and other production equipment as trained and authorized. Check equipment status, cleaning labels, and operational readiness before use. Coordinate with maintenance personnel in case of equipment breakdown. Maintain equipment usage records and logbooks. Follow equipment safety procedures and preventive maintenance requirements. E. Safety and Environmental Compliance Follow EHS guidelines and use the required personal protective equipment (PPE). Handle chemicals, solvents, acids, and alkalis according to approved procedures. Follow permit-to-work requirements and applicable safety precautions. Report unsafe conditions, near misses, and incidents immediately. Follow approved waste disposal and environmental protection procedures. F. Coordination and Reporting Coordinate with production supervisors, QA, QC, stores, engineering, and utility departments. Communicate batch status and pending activities during shift handovers. Assist in achieving daily and monthly production targets. Participate in GMP, safety, and process-related training programs. Follow instructions from the reporting manager and maintain discipline on the production floor. 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 1–4 years of experience in API manufacturing. Freshers may be considered for trainee or entry-level officer positions, depending on company policy. Hands-on knowledge of chemical synthesis, batch processing, and production documentation is preferred.