Assistant Manager Injectable

Job Description

Production & Operations Management: Oversee and manage the ampoule & vial filling operations in the injectable production unit. Ensure smooth production planning to meet targets while maintaining quality and compliance. Optimize machine efficiency, reduce downtime, and troubleshoot issues in the filling process. Monitor batch documentation, process validation, and standard operating procedures (SOPs) . Quality & Compliance: Ensure strict adherence to cGMP, USFDA, WHO, MHRA, and other regulatory guidelines . Conduct regular audits and inspections to maintain high-quality production standards. Investigate and resolve deviations, non-conformities, and CAPAs (Corrective and Preventive Actions). Coordinate with the Quality Assurance (QA) and Quality Control (QC) teams for compliance. Manpower Management: Lead, train, and supervise the production team, ensuring productivity and skill development. Assign tasks efficiently and ensure adherence to SOPs and safety protocols . Motivate and guide the team to improve efficiency and maintain discipline on the shop floor. Process Improvement & Documentation: Identify and implement continuous improvement initiatives (Lean, Six Sigma, etc.) in the injectable manufacturing process. Maintain and review Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs) . Collaborate with engineering and maintenance teams for equipment upkeep and process enhancements. Key Requirements: Education & Experience: B.Pharm / M.Pharm / B.Sc / M.Sc in Pharmaceuticals, Chemistry, or a related field. 5-10 years of experience in Injectable Manufacturing, specifically ampoule & vial filling . Strong knowledge of GMP, regulatory audits, and sterile manufacturing processes . Skills & Competencies: Expertise in ampoule & vial filling machines (Rommelag, Bausch+Strbel, etc.). Strong leadership and manpower handling abilities. Problem-solving skills with a continuous improvement mindset . Knowledge of EHS (Environment, Health & Safety) guidelines . Experience with regulatory audits (USFDA, WHO, GMP, MHRA, etc.) . Role & responsibilities