Researcher with a demonstrated history of 12 years of working experience in pharmaceutical industry widely in QMS, Compliance for GxP wrt Process and Computer System, 21 CFR part 11, Annex 11, GAMP5, Regulatory Compliance Requirement (FDA, WHO, TGA, Health Canada etc) and their Adherence.# Sound experience for providing effective CAPA, Investigations, Change Control & Evaluation of Deviations and RCA (Root Cause Analysis).# Expert in providing the road map of Validation of application/IT Projects (Validation Plan) and assessing the Vendor, System Classification, System Requirement Risk Assessment, ERES requirement (Electronic Record Electronic Signature), Periodic Review, CS ( Role & Privileges)# Enough Experience in delivering the Validation of IT projects Like - PMS, NuGenesis, LMS, Stand-alone QC Instruments - Vitros250, PLC validation, UV, other software’s like - SAS, Analyst Software, Phoenix.