Amneal Pharmaceuticals, Inc. is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high- quality medicines.
Post : Executive / Senior Executive - QA
Validation, Qualification & IPQA | Sterile Injectables
Role Summary : Looking for an Executive / Senior Executive - QA to own validation, qualification and In-Process Quality Assurance (IPQA) activities at our sterile injectable manufacturing facility. This is a shop-floor-facing role for someone who understands aseptic processing and can hold the line on sterility assurance and data integrity every single shift.
Job Description
Validation & Qualification
• Prepare, review and execute URS, DQ, IQ, OQ and PQ protocols and reports for equipment, utilities and facilities (WFI, PW, Pure Steam, Compressed Air/Nitrogen, HVAC).
• Drive process validation (PPQ) and continued process verification for injectable products.
• Execute and review cleaning validation, hold-time studies, sterilization validation (autoclave, DHS/depyrogenation tunnel), filter integrity testing and sterilizing filter validation.
• Plan, monitor and report media fills / aseptic process simulations, including intervention design and result evaluation.
• Carry out thermal mapping of autoclaves, ovens, cold rooms and stability chambers; maintain requalification schedules.
• Maintain the Validation Master Plan and support computer system validation and data-integrity compliance (21 CFR Part 11,
EU Annex 11).
In-Process Quality Assurance (IPQA)
• Provide line clearance and online quality oversight across dispensing, compounding, filtration, filling, sealing, lyophilization, visual inspection and packing.
• Monitor aseptic behaviour, gowning practices and environmental monitoring compliance in Grade A/B areas.
• Perform in-process checks (fill volume, sealing integrity, leak test) and in-process sampling as per approved procedures.
• Review BMRs/BPRs, logbooks and audit trails; ensure real-time, contemporaneous documentation on the floor.
• Initiate and close deviations, change controls. CAPAs and OOS/OOT investigations within timelines.
• Support regulatory inspections and customer audits, including preparation, backroom support and response closure.
Skills & Qualification :
• Strong technical writing, investigation and root-cause analysis skills.
• Practical understanding of contamination control strategy, sterility assurance and aseptic techniques.
• Hands-on exposure in validation, qualification and IPQA within a sterile/injectable facility.
Candidate Profile
Qualification : B.Pharm / M.Pharm / M.Sc (Chemistry or Microbiology)
Experience : 5-8 years in Quality Assurance within a sterile/injectable formulation facility.
Working knowledge of EU GMP Annex 1 (2022),
21 CFR Parts 210/211, WHO GMP and ICH Q7-Q10.
Experience supporting USFDA. EU GMP, MHRA, TGA or WHO inspections is an added advantage.
Interested candidates can share their CVs to below mail ID : nechar.trivedi@amneal.com
Disclaimer : Amneal ensures equal job opportunities and does not charge applicants for employment or authorize any agency to collect fees for recruitment.
Amneal Pharmaceuticals. Inc. (NYSE: AMRX) is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high-quality medicines.
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