Amneal is hiring for the position of Officer, QA Validation in Ahmedabad City, Gujarat. The role focuses on equipment, HVAC, classified areas, utilities, validation documentation, qualification activities, and compliance-related tracking within sterile manufacturing operations.
Job Details
| Particular | Details |
|---|---|
| Company | Amneal |
| Position | Officer, QA Validation |
| Location | Ahmedabad City, Gujarat, India |
| Experience | 2–5 years |
| Required Education | B.Pharm |
| Preferred Education | M.Pharm |
| Other Eligible Qualifications | M.Sc. in Chemistry or Microbiology; B.E./B.Tech in Biotechnology or Chemical Engineering |
Position
Officer, QA Validation
The Officer, QA Validation will be responsible for qualification and validation activities covering sterile manufacturing equipment, HVAC and classified areas, utilities, documentation, calibration verification, and validation status tracking.
Key Responsibilities
- Prepare, execute, compile, and review URS, DQ, IQ, OQ, and PQ protocols and reports for sterile manufacturing equipment.
- Work with equipment including vial and ampoule washing machines, depyrogenation tunnels, autoclaves, filling and sealing lines, capping machines, lyophilizers, RABS or isolators, CIP/SIP skids, and inspection machines.
- Participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) and confirm closure of findings before IQ begins.
- Qualify and requalify HVAC systems and classified areas, including HEPA filter integrity, particle counts, pressure differentials, temperature, humidity, recovery and clean-up time, and containment leak testing.
- Coordinate and review airflow visualisation (smoke) studies for Grade A zones.
- Qualify and requalify utilities including Purified Water, Water for Injection, Pure Steam, compressed air, nitrogen, and other process gases.
- Maintain the Validation Master Plan, annual validation and requalification schedule, and equipment and utility qualification status matrix.
- Verify calibration, preventive maintenance, and instrument traceability before qualification activities.
- Prepare and maintain the traceability matrix linking user requirements with qualification test cases and acceptance criteria.
Eligibility & Qualifications
Educational Qualification
- B.Pharm – Required
- M.Pharm – Preferred
- M.Sc. in Chemistry or Microbiology
- B.E./B.Tech in Biotechnology or Chemical Engineering
Experience
- 2–5 years of experience
Required Skills & Knowledge
Candidates should have knowledge or experience related to:
- QA Validation
- URS, DQ, IQ, OQ and PQ
- Sterile manufacturing equipment qualification
- FAT and SAT
- HVAC qualification and requalification
- Classified area qualification
- HEPA filter integrity testing
- Non-viable particle counting
- Airflow visualisation/smoke studies
- Utility qualification
- Validation documentation and traceability
- Calibration and instrument traceability
- Validation Master Plan and qualification status tracking
Application Details
Position: Officer, QA Validation
Company: Amneal
Location: Ahmedabad City, Gujarat, India
Experience: 2–5 years
Required Qualification: B.Pharm