Senior Officer

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.
Hands-on experience in chemical synthesis, batch processing, and production documentation.
Working knowledge of cGMP, BMRs, SOPs, equipment handling, and industrial safety.
5. Required Skills
Knowledge of API manufacturing processes and chemical reactions.
Understanding of GMP documentation and data integrity.
Basic troubleshooting and process monitoring skills.
Team coordination, communication, and reporting skills.
Ability to work in shifts and meet production schedules.
6. Key Performance Indicators (KPIs)
Achievement of assigned production targets.
Batch yield and cycle time performance.
Accuracy and completeness of BMR documentation.
Compliance with GMP, SOPs, and EHS requirements.
Reduction in process losses and equipment downtime.
Timely reporting of deviations and completion of assigned CAPAs.
Training compliance and housekeeping standards.
Note: This JD can be customized based on the specific API process, manufacturing facility, and company requirements.

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Officer API production JD

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Here is a professional Job Description (JD) for Officer – API Production in a pharmaceutical manufacturing company.

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Job Description: Officer – API Production
Department: Production – API
Designation: Officer – Production
Reports To: Senior Officer / Executive / Assistant Manager – Production
Industry: Pharmaceutical – Active Pharmaceutical Ingredients (API)

1. Job Purpose
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.