Officer, QA Validation

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad is seeking a skilled Validation/QA professional to prepare and review qualification protocols for sterile manufacturing equipment, including washing machines, depyrogenation tunnels, autoclaves, filling/sealing lines, capping machines, lyophilizers and isolators.

You will participate in FAT/SAT, qualify HVAC systems and utilities, coordinate smoke studies in Grade A zones, and maintain the Validation Master Plan with periodic reviews.

Qualifications

• Must possess B.Pharm or M.Pharm or M.Sc in Chemistry or Microbiology, or BE/B.Tech in Biotechnology or Chemical Engineering.
• 2–5 years of experience in qualification/validation for sterile manufacturing equipment.
• Strong knowledge of IQ/OQ/PQ protocols, validation lifecycle and GMP requirements.

Responsibilities

• Prepare, execute, compile and review URS, DQ, IQ, OQ and PQ protocols and reports for sterile manufacturing equipment.
• Participate in FAT and SAT for new equipment and ensure closure of findings before IQ begins.
• Qualify HVAC systems and classified areas, including PAO/DOP, HEPA integrity, particle counts, pressure, temp and humidity.
• Coordinate and review airflow visualization (smoke) studies for Grade A zones and retain recordings as evidence.
• Qualify utilities: PW, WFI, Pure Steam, compressed air, nitrogen and other process gases, including three-phase water system qualification and data trending.
• Maintain Validation Master Plan, annual schedule and qualification status matrix; flag due items monthly.
• Verify calibration, preventive maintenance and instrument traceability before qualification execution.
• Prepare traceability matrix linking user requirements to test cases and acceptance criteria.

Skills

URS, DQ, IQ, OQ, PQ protocols

GxP/Validation

HVAC validation

Cleanroom operation

QA coordination

Education

B.Pharm

M.Pharm

M.Sc. Chemistry

M.Sc. Microbiology

B.E./B.Tech Biotechnology

B.E./B.Tech Chemical Engineering

Job description

Key Responsibilities

JOB DESCRIPTION

• 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

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience:

• 2 years or more in 2 - 5 Years