Senior Executive

Job Purpose

To ensure safe, compliant and efficient execution of API manufacturing operations as per approved processes, BMRs and SOPs, while achieving production targets, maintaining product quality and ensuring compliance with cGMP, EHS and regulatory requirements.

Key Responsibilities

• Execute day-to-day API manufacturing activities as per approved BMR, SOPs and production plans.
• Operate and monitor manufacturing processes including charging, reaction, heating/cooling, distillation, extraction, filtration, centrifugation, drying and material transfer.
• Ensure production batches are completed within defined quality, yield and cycle-time parameters.
• Monitor critical process parameters such as temperature, pressure, vacuum, pH, agitation, flow and reaction time.
• Ensure proper equipment line clearance, cleaning and readiness before batch initiation.
• Coordinate with QA/QC for sampling, analysis, process checks and batch release activities.
• Coordinate with Engineering, Utility, EHS, Warehouse and Maintenance teams for smooth production operations.
• Ensure adherence to cGMP, SOP, BMR, GDP and data-integrity requirements.
• Review and complete batch documentation accurately and in a timely manner.
• Identify process deviations, abnormalities and breakdowns and escalate them to the concerned manager.
• Participate in deviation investigation, RCA, CAPA and change-control activities.
• Monitor batch yield, solvent consumption, raw-material usage and process losses.
• Drive initiatives for yield improvement, productivity enhancement, cycle-time reduction and cost optimization.
• Ensure proper handling and storage of hazardous, flammable and process chemicals.
• Strictly follow PTW, LOTO, PPE, safety and emergency-response procedures.
• Ensure proper housekeeping and 5S within the production area.
• Supervise and guide Officers, Operators, Technicians and contract manpower during shift operations.
• Ensure effective manpower deployment and shift-wise work allocation.
• Conduct proper shift handover and communicate pending/critical activities to the next shift.
• Support plant validation, qualification, technology transfer, scale-up and process improvement activities.
• Participate in internal, customer and regulatory audits and ensure timely closure of observations.
• Train team members on process SOPs, GMP, safety and operational practices.

Technical Competencies

• Strong knowledge of API manufacturing processes and equipment.
• Knowledge of reactors, centrifuges, ANFD/filters, dryers, vacuum systems, distillation systems and transfer systems.
• Good understanding of batch manufacturing and process control.
• Knowledge of GMP, GDP, data integrity and pharmaceutical documentation.
• Understanding of DCS/PLC-based process operations will be an advantage.
• Good troubleshooting and problem-solving skills.
• Knowledge of solvent handling and process safety.

Key Performance Indicators

• Production plan achievement %
• Batch cycle-time adherence
• Batch yield and productivity
• Right First Time (RFT)
• Reduction in process deviations
• Solvent/raw-material consumption
• Equipment utilization and downtime
• GMP/documentation compliance
• Safety and incident-free operations
• CAPA/deviation closure
• Manpower productivity
• Cost optimization and process improvement initiatives