Head of Manufacturing

As the Head of Manufacturing API, your role is crucial in leading all API production activities to ensure safe, compliant, and efficient manufacturing operations. You will be responsible for achieving production targets, maintaining cGMP compliance, and driving continuous improvement across the API manufacturing units. Key Responsibilities: - Production Management - Plan and execute API manufacturing as per production schedules. - Ensure adherence to batch production records (BMRs) and standard operating procedures (SOPs). - Optimize process yields and reduce production cycle time. - Review and approve production documentation. - Compliance & Quality Assurance - Ensure full compliance with cGMP, ICH, and regulatory requirements (USFDA, EMA, WHO, etc.). - Coordinate with QA/QC for timely release and in-process quality checks. - Support regulatory inspections and customer audits. - Implement corrective and preventive actions (CAPAs) and change controls. - Team Leadership & Development - Lead and manage a team of production managers, supervisors, and operators. - Provide training and performance management to manufacturing staff. - Foster a culture of safety, quality, and operational excellence. - Safety & Environment - Enforce EHS (Environment, Health & Safety) policies and ensure zero accidents. - Lead risk assessments and incident investigations. - Monitor effluent treatment and hazardous waste management. - Process Improvement & Technology Transfer - Collaborate with R&D and Tech Transfer for smooth scale-up and validation. - Support new product introductions (NPI) and technology transfers from R&D or other sites. - Budget & Cost Control - Manage manufacturing budgets, OEE (overall equipment effectiveness), and resource planning. - Monitor raw material and solvent usage for cost optimization. - Work with procurement to ensure timely availability of materials. Qualifications Required: - 20+ years of experience in API manufacturing. - Education: B.Sc. / M.Sc. in Chemistry or B.E. / B.Tech. in Chemical Engineering (Masters preferred). (Note: No additional details of the company were provided in the job description.),