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 strong 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.
- Strong 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