Role & responsibilities
Lead QA, QC & Microbiology functions and define overall Quality strategy.
Establish and continuously improve QMS, SOPs, CAPA, Change Control, Deviations, OOS/OOT, Risk Management and Document Control.
Ensure GMP compliance across manufacturing, packaging, warehousing and distribution.
Oversee batch documentation, product disposition and batch release.
Lead QC laboratory activities, analytical testing, investigations and equipment qualification/calibration.
Drive Microbiology, environmental monitoring and contamination-control programs.
Lead regulatory inspections and customer audits including exposure to USFDA, EU and CE/MDR requirements.
Oversee validation & qualification of facility, equipment, utilities, processes, cleaning, analytical methods and computerized systems.
Manage customer complaints, recalls, PMS and quality risk management.
Lead supplier qualification, vendor audits, Quality Agreements and supplier CAPA.
Provide Quality support for NPD,



technology transfer, process validation and commercialization.
Drive Quality improvement, Right-First-Time, Lean Quality and reduction of deviations, CAPA, complaints and OOS.
Build and develop a solid QA, QC & Microbiology team and succession pipeline.

Preferred candidate profile
15+ years of progressive Quality experience in Pharma, Medical Devices, Infection Prevention, Disinfectants, Healthcare or other regulated industries.
Robust leadership experience across QA/QC/Microbiology.
Strong knowledge of Global GMP, QMS and international regulatory requirements.
Experience in USFDA / EU / CE-MDR / customer audits preferred.
Strong expertise in CAPA, Change Control, OOS/OOT, QRM, Validation, Data Integrity and Audit Management.
Experience managing multidisciplinary Quality teams in a manufacturing setting.

📌 Head Quality Tarapur
🏢 Symphoni HR
📍 Tarapur