API Production Manager

Role & responsibilities

• Plan, organize, and monitor daily API production activities to achieve production targets as per the approved schedule.
• Ensure all manufacturing operations comply with cGMP, approved SOPs, BMRs, regulatory requirements, and EHS standards.
• Manage production planning, manpower deployment, shift operations, and optimum utilization of equipment and resources.
• Monitor batch processing, process parameters, yield, productivity, and manufacturing costs.
• Ensure timely and accurate completion of batch manufacturing records, equipment logs, and other production documentation.
• Coordinate with QA, QC, Engineering, Warehouse, and other departments to ensure smooth manufacturing operations.
• Review and investigate production deviations, process failures, out-of-specification events, and implement CAPA in coordination with QA.
• Ensure equipment cleaning, line clearance, preventive maintenance coordination, and production area readiness.
• Drive process optimization, yield improvement, waste reduction, and continuous improvement initiatives.
• Ensure compliance with safety procedures, chemical handling practices, housekeeping, and 5S standards.
• Train, guide, and develop production personnel to improve technical competency, discipline, and performance.
• Monitor production KPIs, prepare reports, and provide regular updates to management on production performance and operational issues.

Preferred candidate profile

• Qualification & Experience: B.Sc./M.Sc. Chemistry, or Chemical Engineering with 12-15 years of experience in API manufacturing, including production team management.

• Technical Knowledge: Strong knowledge of API manufacturing processes, cGMP, regulatory compliance, process validation, BMRs, yield optimization, and deviation/CAPA management.

• Key Competencies: Proven leadership, production planning, manpower management, cross-functional coordination with QA/QC and Engineering, and the ability to achieve production targets while ensuring quality, safety, and compliance.