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).