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6–10 years of relevant experience in API production, including 2–4 years in a supervisory/shift-lead role.

Job Overview Responsible for managing all production activities during the assigned shift to achieve production targets while ensuring compliance with cGMP, SOPs, safety requirements, quality standards, and approved manufacturing procedures.

Key Responsibilities Lead and supervise complete API manufacturing operations during the assigned shift. Ensure production activities are executed according to the approved BMR/BPR, SOPs, and production schedule. Allocate manpower and ensure effective utilization of operators and production resources. Monitor critical process parameters and ensure operations remain within approved limits.

Supervise activities such as: Reactor charging and reaction Heating/cooling pH adjustment Extraction Filtration/centrifugation Washing Drying Milling/sieving Blending Material transfer and packing Ensure equipment and production areas are ready before starting batch operations. Coordinate with QA/QC for line clearance, sampling, in-process testing, and batch-related activities. Coordinate with Engineering/Maintenance for equipment breakdowns and maintenance requirements.

Monitor batch progress, cycle time, yield, productivity, and production losses. Review batch records and ensure complete and accurate documentation during the shift. Identify and report process deviations, equipment abnormalities, and safety incidents immediately.

Participate in deviation, OOS/OOT-related support, CAPA, change control, and RCA activities as applicable. Ensure strict compliance with cGMP, GDP, ALCOA+ data-integrity principles, SOPs, and EHS requirements. Ensure proper handling and storage of chemicals, solvents, intermediates, and APIs.

Maintain production-area housekeeping, 5S, and safety standards.



Conduct effective shift handover and communicate batch status, abnormalities, and pending activities to the next shift. Train and guide operators on SOPs, GMP, safety, and equipment operation.

Support process validation, cleaning validation, technology transfer, scale-up, and trial batches. Support internal, customer, and regulatory audits. Prepare shift production reports and communicate key performance indicators to Production Management.

Team Management

Supervise production operators, technicians, and junior production personnel. Allocate manpower according to batch requirements and production priorities. Monitor employee performance, discipline, attendance, and training requirements.

Conduct toolbox talks and reinforce safe working practices. Ensure adequate staffing and competency for critical manufacturing operations. Technical & GMP Knowledge Strong knowledge of API manufacturing processes and equipment.

Good understanding of reactors, centrifuges, filters, dryers, mills, blenders, pumps, and vacuum systems. Knowledge of cGMP, GDP, ALCOA+, deviation, CAPA, change control, and risk assessment. Understanding of process safety and hazardous chemical/solvent handling.

Ability to troubleshoot process and equipment-related issues. Positive knowledge of batch documentation and manufacturing records. Qualification B.E./B.Tech – Chemical Engineering or M.Sc. Chemistry / B.Pharm / M.Pharm, depending on the organization's requirements.

Key Performance

Indicators (KPIs) Achievement of shift production targets Batch yield and productivity Batch cycle-time adherence Right-First-Time (RFT) performance Reduction in production deviations GMP/documentation compliance Equipment utilization Safety performance Reduction in production losses Effective manpower utilization Timely and accurate shift handover

📌 Assistant Manager (Mumbai)
🏢 DigiCAD
📍 Mumbai