Officer/Senior Officer/Executive

Role & responsibilities :

• Supervise sterile manufacturing processes such as compounding, filtration, filling, and sealing of injectable products.
• Ensure compliance with cGMP, FDA, and other regulatory requirements in all production activities.
• Monitor and control environmental conditions in aseptic areas, ensuring cleanroom discipline is maintained.
• Coordinate with quality control, quality assurance, and engineering departments for production-related activities.
• Review and maintain batch manufacturing records (BMR), logbooks, and other relevant documentation.
• Perform in-process checks and ensure timely reporting of deviations and non-conformances.
• Assist in validation activities including media fill, equipment qualification, and process validation.
• Train and guide production staff on aseptic techniques, gowning procedures, and SOP adherence.
• Ensure timely availability of materials, equipment, and manpower for smooth production operations.
• Participate in internal and external audits and support compliance initiatives.

Preferred candidate profile

• Education: B.Pharmacy/ M.Sc.
• Experience: 1-7 years in injectable (sterile) production in a pharmaceutical company.
• Knowledge of aseptic processing and cleanroom protocols.
• Familiarity with equipment like autoclaves, vial washers, filling lines, lyophilizers, and isolators.
• Understanding of documentation and regulatory requirements (e.g., USFDA, EU GMP, WHO GMP).