Sanjay Izardar
Senior QA & Compliance Professional | GMP Auditor | QMS & Data Integrity Expert | 19+ yrs in Regulated Pharma
- Role
- Head Qms at Swati
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Sanjay Izardar
Senior Pharmaceutical Quality & Compliance Professional | GMP Auditor | QMS & Data…
Experience
Head Qms
Oct 2021 — Present · Vapi, IN
Seasoned Quality and Compliance professional with extensive experience driving GMP/GxP compliance across global pharmaceutical and biopharmaceutical operations. Demonstrated expertise in conducting over 200 quality audits and regulatory inspections (USFDA, MHRA, EDQM, TGA, ANVISA), with a focus on inspection readiness, data integrity, and QMS governance. Proven track record in managing critical quality systems—including deviation and CAPA management, change control, complaint handling, and OOS/OOT/OOC investigations—in alignment with ICH Q9/Q10, 21 CFR, and EU GMP requirements.Skilled in implementing robust Quality Management Systems (QMS), leading electronic quality systems (eQMS) such as TrackWise, and conducting risk-based supplier audits and vendor qualifications. Adept at regulatory filing support, deficiency response, and validation lifecycle oversight (PPQ, PV). Recognized for developing sustainable compliance frameworks and leading corporate-level data integrity initiatives.
Education
School of chemical science DAVV Indore
M.Sc. Pharmaceutical Chemistry
2002 — 2004
Skills
- Glp
- Gmp
- Equipment Qualification
- Pharmaceuticals
- Cgmp
- Validation
- Sop
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