Profile: Quality Assurance (QA) Professional associated with Pharma Lifesciences and Healthcare with 15+ years of experience in Clinical Research and Quality Assurance activities. PVQA Functional Subject Matter Expert. Lead Auditor: GVP(Major), GCP and Vendor Audit Programs. Leading and Supporting Customer Audits and Regulatory Inspections (MHRA, US FDA, HPRA and TGA). Quality Management System - Compliance & Strategy. Risk and Trend Analysis. Deviations, CAPA Management with Effectiveness Checks. Creation and Periodic reviews of QA SOPs, process WIs /project instructions and QMS procedures. System Experience: e-QMS - EDA (Event Driven Analysis)/Track wise e-QMS - RAVEN: Customer Audits and Inspections hosting system PV Systems: ARISg, ARGUS, Professional Systems Automations for Signal Management. Certified Lead Auditor ISO 9001-2015, Six Sigma and Green Belt. Languages Known: English, Hindi and Konkani. Work Location: Homebased, India. Based in Mumbai. Audit services are for PV Pharma clients operational in India, Ireland and GB.