Head of Production

Job Description

Job Title : Production Head – API (Active Pharmaceutical Ingredients) Industry : Pharmaceuticals – API Manufacturing Location : Uttarakhand CTC : ₹20–25 LPA Education : B. Pharma / M. Pharma Experience : 15–20 years in API production and R&D within reputed pharmaceutical companies Position Summary We are seeking a highly experienced and dynamic Production Head to lead our API Manufacturing operations. The ideal candidate will possess deep technical knowledge, leadership capabilities, and a proven track record of managing large-scale pharmaceutical manufacturing units while maintaining compliance with cGMP and global regulatory standards. Key Responsibilities 1. Production Planning & Execution Lead end-to-end production operations ensuring timely delivery and optimal yield. Develop and manage daily, weekly, and monthly production schedules aligned with demand forecasts. Ensure optimal resource utilization – manpower, machinery, and materials. Monitor capacity and proactively mitigate risks of bottlenecks or inefficiencies. 2. Technology Transfer & Implementation Review and implement technology transfer documents from R&D. Oversee the successful integration of new products and technologies into the production line. Ensure adherence to validated processes, safety norms, and regulatory requirements. Troubleshoot process issues to ensure uninterrupted operations. 3. Quality & Regulatory Compliance Enforce strict adherence to cGMP, PIC/S, ICH, and other international regulatory standards. Review and maintain comprehensive documentation including BMRs, SOPs, and validation protocols. Coordinate with QA/QC teams for inspections, audits, and quality investigations. Maintain readiness for audits by regulatory authorities (e.g., USFDA, WHO, EUGMP). 4. Engineering & Maintenance Coordination Ensure all production equipment is well-maintained and calibrated. Collaborate with the Engineering team for preventive maintenance schedules. Minimize downtime through proactive planning and quick resolution of technical issues. 5. Cross-Functional Coordination Liaise with Procurement, Stores, CRD/ARD, QA, QC, and Warehouse for seamless operations. Ensure compliance with work permit systems and EHS regulations across departments. 6. Environmental, Health & Safety (EHS) Lead safety programs and enforce a strong safety culture across the production floor. Conduct risk assessments (e.g., HAZOP studies) and ensure environmental compliance. Implement best practices in waste disposal, emission control, and chemical handling. 7. Team Management & Culture Building Lead, mentor, and develop a high-performing production team. Implement training programs for skill enhancement and GMP compliance. Promote discipline, accountability, and a culture of continuous improvement. 8. Inventory Management Monitor inventory levels of raw materials, intermediates, solvents, and finished goods. Coordinate solvent recovery and efficient raw material utilization. Work with ERP software (e.g., SAP, Tally, Marg) for stock tracking and reporting. 9. Cost Control & Budgeting Monitor production expenses and identify cost-saving opportunities. Assist in annual budgeting and monthly forecasting of production costs. Generate regular MIS reports including yield, solvent recovery, uptime, and efficiency. Key Competencies Strong knowledge of API manufacturing processes Expertise in GMP, regulatory compliance, and quality systems Leadership in managing large teams and cross-functional collaboration Excellent analytical, troubleshooting, and decision-making skills Proficiency in ERP systems and production planning tools Show more Show less