Computer system Validation professional, currently pursuing “M.Tech Computing system and Infrastructure” work integrated learning programme from BITS pilani.About 11+years of extensive experience in Computer system validation, Quality Assurance, IT Compliance and exposure to various Software connected Manufacturing equipment' s, Laboratory instruments, Engineering system and IT applications in regulated pharmaceutical industries.Good Exposure on GxP Regulations and Quality and Compliance: GAMP 5, Data integrity, ICH, US FDA-21 CFR Part 11, EU Vol 4 Annex 11, SDLC, Quality Management Systems (Change Management, Deviation and CAPA) Risk assessment- GxP assesments, Functional risk assesments, GAP assessment, FMEA methods and System operation management.Experts in Computer system validation for enterprises applications such as Trackwise, Document management system, Valgenesis, ComplianceWire, SAP S/4 HANA , LIMS, Tracelink , Laboratory systems & Manufacturing Automation system like SCADA/DCS/HMI/PLC and Equipment/Engineering system Qualification.