Job Title

1. Purpose of the Role To plan, direct, and control API production operations to achieve targeted output, quality, cost efficiency, and regulatory compliance while ensuring safe, GMP-compliant, and environmentally responsible manufacturing. 2. Key Responsibilities A. Production Planning & Operations Plan, execute, and monitor day-to-day API manufacturing activities as per approved production schedules. Ensure optimum utilization of men, machinery, materials, and utilities. Achieve production targets with minimal downtime and wastage. Coordinate with Planning, QC, QA, Engineering, and Stores for uninterrupted production flow. B. GMP & Regulatory Compliance Ensure compliance withcGMP, WHO-GMP, USFDA, EU-GMP, and other regulatory standards . Implement and maintain SOPs, BMRs, logbooks, and manufacturing documentation. Ensure adherence to validated processes and approved change control procedures. Support regulatory audits and inspections; ensure timely closure of observations. C. Quality & Process Control Ensure production is carried out as per approved batch manufacturing records. Monitor critical process parameters and ensure product quality consistency. Investigate deviations, OOS/OOT, and implement CAPA in coordination with QA. Drive continuous improvement initiatives to enhance yield and reduce reprocessing. D. Safety, Health & Environment (EHS) Enforce safe operating practices and compliance with EHS norms. Ensure proper handling, storage, and disposal of hazardous chemicals and waste. Promote safety culture, conduct toolbox talks, and ensure incident reporting and investigation. E. Team Management & Development Lead, mentor, and supervise production officers, supervisors, and operators. Conduct training on SOPs, GMP, safety, and process improvements. Monitor manpower deployment, shift planning, and performance evaluation. Foster discipline, teamwork, and accountability on the shop floor. F. Cost Control & Efficiency Monitor and control production costs, consumables, and energy usage. Improve batch cycle times, yields, and overall equipment effectiveness (OEE). Support budgeting and cost-reduction initiatives. G. Coordination & Reporting Prepare and review daily, monthly production reports and MIS. Coordinate with Supply Chain, QA, Engineering, and Maintenance for smooth operations. Escalate critical issues impacting safety, quality, or production timelines.3. Educational Qualification B.Tech / B.E. in Chemical Engineering(Mandatory) 4. Experience Requirements 10–15 yearsof experience in API manufacturing, with at least4–5 years in a managerial/supervisory role . Hands-on experience in large-scale API production operations. 5. Technical & Functional Skills Strong knowledge of API manufacturing processes and unit operations. In-depth understanding of GMP, regulatory guidelines, and audit requirements. Process optimization, troubleshooting, and yield improvement skills. Working knowledge of SAP/ERP systems and MS Office. 6. Behavioral Competencies Strong leadership and decision-making ability. Excellent communication and cross-functional coordination skills. High integrity, discipline, and compliance mindset. Ability to work under pressure in a regulated manufacturing environment. 7. Compliance & Accountability Responsible for adherence to company policies, statutory requirements, and regulatory standards. Accountable for production output, quality, safety, and manpower management within the assigned API block.