Job Purpose To lead and manage API production operations, ensuring safe, efficient, compliant and cost-effective manufacturing of Active Pharmaceutical Ingredients (APIs) in accordance with cGMP, regulatory requirements, EHS standards and approved production plans. The role is responsible for production planning, process execution, resource utilization, batch quality, productivity improvement and development of the production team.

- Key Responsibilities

A. API Production Operations
- Lead day-to-day API manufacturing operations, ensuring adherence to approved batch manufacturing records (BMRs), standard operating procedures (SOPs) and production schedules.
- Manage end-to-end manufacturing processes, including charging, reactions, distillation, extraction, crystallization, filtration, drying, milling, blending and packing, as applicable.
- Ensure timely execution and completion of production batches in line with approved plans and customer requirements.
- Monitor batch cycle times, yields, solvent recovery, equipment utilization and process performance.
- Coordinate with Production Planning, Quality Assurance, Quality Control, Engineering and Warehouse teams to ensure uninterrupted manufacturing operations.
- Ensure proper execution of shift handovers and effective deployment of manpower across production shifts.

B. cGMP and Regulatory Compliance
- Ensure compliance with current Good Manufacturing Practices (cGMP), applicable regulatory requirements and company quality systems.
- Review and ensure accurate completion of BMRs, logbooks, equipment usage records and other production documentation.
- Ensure compliance with data integrity requirements, documentation practices and audit-trail controls.
- Investigate deviations, batch failures, out-of-specification (OOS) results and process discrepancies in coordination with QA and QC.
- Drive CAPA implementation, change control, risk assessments and prevention of recurring quality issues.
- Support internal audits, customer audits and regulatory inspections, including USFDA and other applicable regulatory authorities.

C. Production Planning and Performance
- Prepare and execute daily, weekly and monthly production plans in line with business requirements.




- Monitor production KPIs, including batch cycle time, yield, productivity, rejection rates, right-first-time performance and schedule adherence.
- Identify bottlenecks and implement process improvements to enhance productivity and reduce manufacturing costs.
- Optimize raw material, solvent, utility and manpower consumption.
- Drive continuous improvement initiatives using root cause analysis, Lean methodologies and process optimization techniques.

D. EHS and Process Safety
- Ensure strict adherence to EHS policies, plant safety procedures and statutory requirements.
- Promote safe handling of hazardous chemicals, solvents, corrosive materials and other process substances.
- Ensure implementation of permit-to-work systems, PPE requirements, lockout/tagout and safe operating practices.
- Coordinate with EHS and Engineering teams on process hazard analysis, risk assessments, incident investigations and corrective actions.
- Ensure emergency preparedness, safe waste handling, effluent management and environmental compliance.
- Promote a strong safety culture and ensure timely closure of safety observations and audit findings.

E. Equipment and Utility Coordination
- Coordinate with Engineering and Maintenance teams to ensure equipment availability and reliability.
- Support preventive maintenance planning, breakdown analysis and timely restoration of production equipment.
- Ensure proper cleaning, line clearance, equipment status identification and changeover activities.
- Coordinate on qualification, calibration and validation activities relevant to production operations.

F. Team Leadership and Development
- Lead, mentor and develop Production Managers, Shift In-charges, Production Officers and shop-floor personnel.
- Plan manpower deployment, shift rosters, training and competency development.




- Establish clear performance objectives and monitor individual and team performance.
- Promote discipline, accountability, teamwork and a continuous improvement culture.
- Ensure training on SOPs, cGMP, EHS and process-specific requirements.

G. Cross-Functional Coordination
- Work closely with QA, QC, Engineering, EHS, Warehouse, Supply Chain and Planning teams.
- Coordinate with R&D;, Process Development and Technology Transfer teams for current product introductions and process scale-up.
- Support investigations into process-related quality issues and implement approved corrective measures.
- Provide regular production performance updates, risks and improvement plans to senior management.

3. Educational Qualification
- B.E./B.Tech. in Chemical Engineering or a relevant engineering discipline; OR
- M.Sc. in Chemistry / Organic Chemistry or an equivalent relevant qualification.
- M.Pharm or other relevant postgraduate qualifications may be considered depending on the candidate's experience and the organization's requirements.

4. Experience
- Overall experience: 12–18 years in pharmaceutical API manufacturing.
- Leadership experience: At least 4–6 years managing production teams, multiple production blocks or significant manufacturing operations.
- Strong hands-on experience in chemical synthesis, batch manufacturing, process troubleshooting and production planning.
- Experience in regulated API manufacturing facilities and exposure to USFDA, WHO-GMP or other international regulatory inspections will be preferred.
- Experience managing complex chemical reactions, hazardous processes and solvent recovery systems will be an advantage.

5. Technical Competencies
- API and batch manufacturing processes.
- Reaction chemistry, process parameters, yield optimization and cycle-time reduction.
- BMR/BPR documentation, SOPs, deviations, CAPA and change control.
- cGMP, data integrity and regulatory audit readiness.
- Process safety, chemical handling and risk assessment.
- Production planning, capacity utilization and manufacturing cost control.
- Root cause analysis, troubleshooting and continuous improvement.
- ERP/SAP knowledge and production MIS reporting.

📌 AGM:- Production (API Site) (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar