Officer QA Validation

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 750,000 - 1,050,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad, India, is seeking an experienced validation professional to lead qualification of sterile manufacturing equipment and utilities. The role focuses on IQ/OQ/PQ, FAT/SAT alignments, and maintaining the Validation Master Plan with monthly status updates.

You will coordinate HVAC and cleanroom qualifications, review calibration status, and ensure traceability of tests from URS to acceptance criteria, supporting regulatory compliance and site readiness.

Qualifications

• B.Pharm, M.Pharm, or B.E./B.Tech in biotechnology or chemical engineering.
• 2+ years experience in 2–5 years in validation of sterile equipment.
• Experience with IQ/OQ/PQ, FAT/SAT and commissioning.
• HVAC and cleanroom qualification experience.

Responsibilities

• Prepare and review URS, DQ, IQ, OQ, PQ protocols and reports for sterile equipment.
• Participate in FAT and SAT and ensure findings closed before IQ.
• Qualify and requalify HVAC systems and classified areas including PAO/DOP tests.
• Coordinate airflow visualization studies and retain recordings.
• Qualify utilities: PW, WFI, Pure Steam, compressed air, nitrogen, etc.
• Maintain Validation Master Plan and annual schedule; flag due items monthly.
• Verify calibration and traceability of measuring devices used in qualification.
• Prepare traceability matrix linking URS to test cases.

Skills

IQ/OQ/PQ

Validation

GXP

HVAC qualification

Sterile manufacturing

Education

B.Pharm

M.Pharm

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

M.Pharm preferred

Tools

Validation Master Plan

Calibration & PM systems

Job description

Job Description:

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 maintenance 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.

Qualifications

Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 2 years or more in 2 - 5 Years