To manage and supervise API manufacturing operations in compliance with cGMP, safety standards, regulatory requirements, and approved standard operating procedures (SOPs), ensuring production targets, product quality, process efficiency, and timely batch completion. 2.

Key Responsibilities
A. Production Operations Plan, execute, and monitor daily API manufacturing activities as per the production plan. Supervise batch manufacturing operations, including charging, reactions, distillation, extraction, filtration, centrifugation, drying, milling, and packing. Ensure adherence to approved Batch Manufacturing Records (BMRs), SOPs, and process parameters. Monitor critical process parameters and ensure consistent product quality and yield. Coordinate with planning, stores, quality control (QC), and quality assurance (QA) for smooth production operations. Ensure timely completion of batches and achievement of production targets. B. GMP and Regulatory Compliance Ensure compliance with current Good Manufacturing Practices (cGMP), data integrity requirements, and applicable regulatory guidelines. Maintain accurate and contemporaneous production documentation. Ensure proper line clearance, equipment cleaning, status labeling, and material traceability. Participate in internal audits, customer audits, and regulatory inspections. Support investigations related to deviations, out-of-specification (OOS) results, and out-of-trend (OOT) results. Implement corrective and preventive actions (CAPA) within agreed timelines. C. Process and Yield Improvement Monitor batch yields, cycle times, solvent consumption, and material utilization. Identify process bottlenecks and implement improvements to enhance productivity. Support process validation, cleaning validation,



technology transfer, and process optimization activities. Analyze production losses and recommend corrective measures to minimize wastage. Assist in scale-up activities and implementation of process changes. D. Equipment and Maintenance Ensure equipment availability, operational readiness, and preventive maintenance coordination. Coordinate with engineering and maintenance teams for breakdown resolution. Ensure equipment qualification status and calibration requirements are maintained. Monitor utility availability and safe operation of reactors, centrifuges, dryers, pumps, and other process equipment. E. Safety and Environmental Compliance Ensure compliance with EHS procedures, PPE requirements, and safe chemical handling practices. Enforce protected practices for handling solvents, acids, alkalis, and hazardous chemicals. Ensure compliance with permit-to-work systems, confined-space entry requirements, and other applicable safety procedures. Support incident reporting, risk assessments, and implementation of safety recommendations. Promote solvent recovery, waste minimization, and environmental compliance. F. Team Management Lead, guide, and supervise production officers, executives, supervisors, and operators. Allocate manpower according to production priorities and shift requirements. Train employees on SOPs, GMP, safety, and process operations.



Monitor employee performance, discipline, and training effectiveness. Develop a culture of accountability, teamwork, and continuous improvement. G. Documentation and Reporting Review BMRs, equipment logbooks, cleaning records, and production reports. Prepare daily, weekly, and monthly production performance reports. Track key performance indicators (KPIs), including production output, yield, batch cycle time, deviations, and downtime. Ensure timely closure of production-related documentation and investigations. 3. Qualification B.
E./B.
Tech in Chemical Engineering or B.
Sc./M.
Sc. in Chemistry. Relevant pharmaceutical manufacturing qualifications and experience in API production are preferred. 4. Experience Typically 7–12 years of experience in API manufacturing, with relevant supervisory or managerial experience. Experience in multi-step synthesis, batch processing, and commercial-scale API manufacturing. Working knowledge of cGMP, SOPs, BMRs, deviations, CAPA, validation, and safety requirements. 5. Required Skills Strong knowledge of API manufacturing processes and chemical reaction operations. Production planning, manpower management, and troubleshooting skills. Knowledge of GMP documentation and regulatory compliance. Good analytical, communication, and problem-solving abilities. Ability to manage production targets without compromising quality or safety. Proficiency in MS Office and production reporting systems. 6. Key Performance Indicators (KPIs) Achievement of monthly production targets. Batch yield and reduction in material losses. Batch cycle time and on-time batch completion. Reduction in equipment downtime.

📌 Deputy Manager (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar