Role & responsibilities 1. Strategic & Operational Leadership Provide strategic direction for overall plant operations aligned with corporate business goals. Develop and implement annual production plans and budgets to meet organizational objectives. Ensure achievement of production targets with optimal resource utilization, yield, and efficiency. Oversee day-to-day functioning of all departments Production, QA, QC, Engineering, EHS, Warehouse, HR, and Administration. 2. Compliance & Quality Management Ensure strict adherence to cGMP , GLP , GDP , EHS , and all relevant regulatory requirements (USFDA, EDQM, WHO, TGA, etc.). Drive compliance with government and regulatory bodies such as CPCB, GPCB, NOC, FDA, and Pollution Control Board requirements. Lead internal and external audits; ensure timely implementation of CAPA (Corrective and Preventive Actions). Maintain and strengthen the Quality Management System (QMS) across all plant operations. 3. Production & Process Excellence Review and approve monthly/annual production schedules and ensure achievement of business plan targets. Drive process optimization, cost reduction, and productivity improvement through lean initiatives and continuous improvement projects. Oversee maintenance of plant equipment and ensure minimal downtime through preventive and predictive maintenance. Approve CAPEX/OPEX budgets and ensure cost-effective plant operations. 4. People Leadership & Development Lead and motivate a multidisciplinary team, ensuring high performance, accountability, and professional development. Build a strong culture of safety, compliance, and teamwork across the plant. Conduct performance reviews, succession planning, and leadership development for key team members. Resolve employee grievances in coordination with HR and maintain healthy industrial relations. 5. Safety, Health & Environment (EHS) Ensure the plant operates in compliance with EHS norms and statutory regulations. Monitor and improve workplace safety through training, audits, and incident investigations. Promote sustainability by reducing waste, controlling emissions, and improving energy efficiency. 6. Coordination & Communication Collaborate with corporate functions (QA, QC, Supply Chain, Engineering, HR, Finance, and Projects) for smooth operations. Interface with statutory bodies and external agencies to ensure timely renewals, inspections, and compliance. Liaise with marketing, purchase, and R&D teams for new product launches, technology transfers, and production planning. 7. Reporting & Governance Prepare and present monthly MIS, performance metrics, and plant P&L reports to senior management. Ensure transparent communication of operational KPIs such as yield, cost, compliance, and manpower efficiency. Lead strategic review meetings and initiate corrective actions for performance gaps. Preferred candidate profile Education: B.E./B.Tech (Chemical Engineering) or M.Sc / M.Pharm (Chemistry / Pharmaceutical Sciences) Experience: 2025 years in API / Bulk Drug manufacturing , with at least 6–8 years in a senior leadership or plant head role. Regulatory Exposure: Experience with USFDA / EDQM / WHO-GMP / TGA approved facilities.
Role & responsibilities Production Management Plan, organize, and monitor day-to-day production activities to ensure timely completion of manufacturing targets. Develop and execute production schedules as per business requirements. Ensure compliance with batch manufacturing records (BMR) and standard operating procedures (SOPs). Compliance and Quality Assurance Ensure strict adherence to cGMP, GLP, and regulatory guidelines throughout the manufacturing process. Maintain the Quality Management System (QMS) in coordination with the QA department. Support internal and external audits (regulatory and customer audits) and implement corrective and preventive actions (CAPA). Process Improvement Identify opportunities for process optimization and efficiency improvements. Participate in technology transfer, scale-up, and validation activities for new products. Implement cost-saving initiatives without compromising on quality and compliance. Personnel Management Supervise, train, and develop production staff to ensure competency and compliance with cGMP. Conduct regular performance appraisals and ensure effective communication across the team. Manage manpower allocation for all shifts efficiently. Safety and Environmental Compliance Ensure compliance with EHS (Environment, Health, and Safety) regulations within the production area. Promote a culture of safety and hygiene in all operations. Coordinate with the ETP and Utility departments to maintain safe and compliant operations. Equipment and Maintenance Ensure production equipment and instruments are qualified, calibrated, and maintained in optimal working condition. Coordinate preventive maintenance and repair activities with the Maintenance department. Coordination and Communication Coordinate with Warehouse, QA, QC, Engineering, ETP, Utility, and HR departments for smooth operations. Communicate production status, deviations, and challenges to senior management. Documentation and Reporting Ensure timely completion and review of all production-related documentation (BMR, BPR, logbooks, etc.). Maintain accurate production records and submit reports as required. Leadership and Representation Act as a designee for the Head of Plant in his/her absence. Foster teamwork and continuous improvement culture within the production department. Preferred candidate profile B.Sc / M.Sc (Chemistry) or equivalent qualification. Minimum 15 - 20 years of experience in API manufacturing, with at least 57 years in a managerial or supervisory role. Strong understanding of cGMP, ICH, and regulatory requirements (USFDA, EMA, WHO, etc.). Proven ability to lead teams, manage production schedules, and coordinate cross-functional activities.