Sanjay Izardar

Head Qms @Swati

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.

School of chemical science DAVV Indore

M.Sc. Pharmaceutical Chemistry