Assistant Manager

o manage and execute day-to-day API manufacturing operations, ensuring production targets, product quality, process safety, regulatory compliance and optimum utilization of manpower and resources. The incumbent will be responsible for handling assigned production blocks, ensuring adherence to cGMP standards, batch manufacturing procedures and operational excellence.
2. Key Roles & Responsibilities
A. API Manufacturing Operations
- Manage day-to-day production activities across assigned API manufacturing blocks.
- Execute manufacturing operations as per approved Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs).
- Handle chemical synthesis operations, including charging, reactions, distillation, extraction, crystallization, filtration and drying.
- Ensure proper execution of manufacturing processes as per approved process parameters.
- Monitor critical process parameters such as temperature, pressure, pH, reaction time and vacuum.
- Ensure proper utilization of reactors, centrifuges, dryers, filters and other manufacturing equipment.
- Coordinate with shift officers and operators for smooth execution of production activities.
- Ensure timely completion of batches as per the production plan.
B. Production Planning & Execution
- Execute daily, weekly and monthly production plans in coordination with Production Planning, QC and other departments.
- Monitor batch cycle time, production yield and equipment utilization.
- Ensure achievement of production targets without compromising quality and safety.
- Identify bottlenecks in manufacturing operations and implement corrective measures.
- Ensure optimum utilization of manpower, raw materials, solvents and utilities.
- Monitor batch progress and report production performance to the reporting manager.
C. GMP & Regulatory Compliance
- Ensure strict adherence to cGMP, GLP and Good Documentation Practices.
- Ensure execution of manufacturing activities as per approved BMRs and SOPs.
- Maintain proper documentation of batch records, equipment logbooks and production reports.
- Ensure implementation of line clearance and equipment cleaning procedures.
- Coordinate with QA for batch documentation review, deviations and change controls.
- Ensure timely closure of audit observations and implementation of CAPA.
- Maintain manufacturing areas in an inspection-ready condition.
D. Process & Yield Management
- Monitor batch yields and investigate process losses and variations.
- Identify opportunities for improving batch cycle time and process efficiency.
- Coordinate with R&D and Technology Transfer teams during process transfer and scale-up activities.
- Support process optimization and continuous improvement initiatives.
- Monitor solvent consumption, raw material utilization and recovery.
- Ensure effective implementation of approved process changes.
E. Equipment & Operational Management
- Ensure proper operation of reactors, centrifuges, tray dryers, ANFDs, filters, condensers and associated equipment.
- Coordinate with Engineering for preventive maintenance and breakdown resolution.
- Ensure equipment availability and operational readiness before batch initiation.
- Monitor equipment cleaning, maintenance and calibration status.
- Minimize equipment downtime through effective coordination with Engineering.
- Ensure proper equipment usage and compliance with equipment-specific SOPs.
F. Safety & EHS Compliance
- Ensure safe handling of chemicals, solvents and hazardous materials.
- Strictly implement PPE requirements and safe operating practices.
- Ensure compliance with permit-to-work systems and safety procedures.
- Monitor compliance with confined space entry, hot work and other applicable safety protocols.
- Ensure proper implementation of process safety practices.
- Report near misses, unsafe conditions and incidents and ensure corrective actions.
- Promote a strong safety culture within the production team.
G. Manpower & Team Management
- Manage shift-wise manpower deployment and ensure optimum utilization.
- Guide and supervise Production Officers, Supervisors, Technicians and Operators.
- Monitor attendance, discipline and work allocation.
- Conduct on-the-job training for operators and technicians.
- Ensure competency development in manufacturing processes and equipment handling.
- Drive employee productivity, accountability and operational discipline.
H. Cross-Functional Coordination
- Coordinate with QA for batch clearance, deviations and documentation.
- Coordinate with QC for sampling, analysis and batch release requirements.
- Work with Engineering and Utilities for equipment and utility availability.
- Coordinate with Warehouse for raw material and solvent availability.
- Work with EHS for process safety and environmental compliance.
- Support validation, qualification and regulatory audit activities.