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Amneal India

Officer, QA Validation

Amneal India Ahmedabad, Gujarat, India

Pharmaceutical Manufacturing · 5,001-10,000 employees

4 h ago Closes in 6d
qa Mid (2-5 yrs) Full-time India
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About the role

The role involves preparing and executing qualification protocols for sterile manufacturing equipment and utilities to ensure compliance. You will also maintain the site Validation Master Plan and oversee the qualification status of all measuring devices and classified areas.

What they look for

Validation Quality Assurance Sterile Manufacturing HVAC Qualification Equipment Qualification Utility Qualification URS DQ IQ OQ PQ Calibration Preventive Maintenance Traceability Matrix Compliance GMP

Requirements

Candidates must hold a degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or Chemical Engineering. A minimum of 2 years of relevant experience in validation within a manufacturing environment is required.

Full description

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.

Qualifications

Education:• B. Pharm B. Pharm - Required

  • M. Pharm M. Pharm - Preferred

Experience:• 2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses:

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