Officer, QA Validation

Amneal Pharmaceuticals; Sanand; Vor Ort; INR 700.000 - 1.200.000; Vollzeit

Zusammenfassung

Amneal Pharmaceuticals LLC in Gujarat invites a Validation Engineer to join our QA/validation team. You will prepare, execute, and review qualification protocols (URS/DQ/IQ/OQ/PQ) for sterile manufacturing equipment and systems and ensure FAT/SAT closure.

The role requires a B.Pharm (with M.Pharm preferred) and 2+ years in 2-5 years experience in validation, HVAC, utilities qualification, and documentation control at a pharmaceutical site in India.

Qualifikationen

• Education requirement: B.Pharm is mandatory; M.Pharm preferred.
• Experience in 2–5 years in pharmaceutical validation and qualification.
• Familiarity with URS/DQ/IQ/OQ/PQ protocols and sterile manufacturing equipment.

Aufgaben

• Prepare, execute, review URS, DQ, IQ, OQ, PQ protocols for sterile equipment.
• Support FAT/SAT and close findings before IQ starts.
• Qualify HVAC systems including air changes, PAO tests, and humidity.
• Review airflow studies (smoke) for Grade A zones.
• Qualify utilities: PW, WFI, steam, compressed air, nitrogen.
• Maintain Validation Master Plan and qualification schedules.
• Check calibrations and instrument traceability before tests.
• Link URS to test cases in a traceability matrix.

Ausbildung

Bachelor of Pharmacy (B.Pharm)

Master of Pharmacy (M.Pharm)

B.E./B.Tech in Biotechnology or Chemical Engineering

Jobbeschreibung

Key Responsibilities:

1. 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.
2. Participate in Factory Acceptance Test and Site Acceptance Test for new equipment, and confirm that FAT/SAT findings are closed before IQ begins.
3. 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.
4. Coordinate and review airflow visualisation (smoke) studies for Grade A zones, covering routine and worst-case interventions, and retain the recordings as qualification evidence.
5. 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.
6. 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.
7. Verify calibration, preventive maintece and instrument traceability status of all measuring devices used in qualification studies before execution.
8. 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

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