Amneal Pharma is hiring for the role of Officer, QA Validation at Ahmedabad City, Gujarat, India and Pipan Plant, Sanand, Gujarat. This on-site role is suitable for candidates with experience in validation activities for sterile manufacturing equipment, utilities and classified areas.
Job Details
| Company | Amneal Pharma |
| Position | Officer, QA Validation |
| Department | Manufacturing |
| Location | Ahmedabad City, Gujarat, India; Pipan Plant, Sanand, Gujarat, |
| Work Mode | On-site |
| Experience | 2-5 Years |
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.
Qualification
- 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
Experience: 2 years or more in 2 – 5 Years
How to Apply
Interested candidates can apply online through the official application link below.