Quality Assurance based in Waghodia, Vadodara. The ideal candidate brings 3-10 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen).

Strengthen QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA, batch release readiness, data integrity ALCOA+, vendor qualification, and regulatory inspection support (USFDA/EMA/WHO). Additional info: Role: IPQA / AQA / Qualification & Validation

Education: M.Pharm with sterile USFDA experience Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

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