About this role
Key Responsibilities:
- Prepare, execute, compile and review URS, DQ, IQ, OQ and PQ protocols and reports for sterile manufacturing equipment: vial and ampoule washing machines, depyrogenation tunnel, autoclaves, filling and sealing lines, capping machines, lyophilizers, RABS or isolators, CIP/SIP skids, and inspection machines.
- Participate in Factory Acceptance Test and Site Acceptance Test for new equipment, and confirm that FAT/SAT findings are closed before IQ begins.
- Qualify and requalify HVAC systems and classified areas — air velocity and air changes per hour, HEPA filter integrity by PAO/DOP challenge, non-viable particle counts at rest and in operation, pressure differential and cascade, temperature and relative humidity, recovery and clean-up time, and containment leak testing.
- Coordinate and review airflow visualisation (smoke) studies for Grade A zones, covering routine and worst-case interventions, and retain the recordings as qualification evidence.
- Qualify and requalify utilities: Purified Water, Water for Injection, Pure Steam, compressed air, nitrogen and other process gases — including three-phase water system qualification and periodic review of trending data.
- Maintain the site Validation Master Plan, the annual validation and requalification schedule, and the equipment and utility qualification status matrix; flag due and overdue items to the reporting manager each month.
- Verify calibration, preventive maintenance and instrument traceability status of all measuring devices used in qualification studies before execution.
- Prepare and maintain the traceability matrix linking user requirements to qualification test cases and acceptance criteria.
Educational Details:
- B.Pharm, M.Pharm, M.Sc. (Chemistry or Microbiology), or B.E. / B.Tech in Biotechnology or Chemical Engineering.
Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 2 years or more in 2 - 5 Years
Specialized Knowledge: Licenses: