Assistant Manager Injectable

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+Ströbel, 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