Over 6 years of experience in Pharmaceutical, OTC, with SDLC, 21CFR part 11 validation, change control management testing and implementation of Business applications.Reviewed and validated computer systems in compliance with 21CFR Part 11 and FDA regulations for Pharmaceutical industries. Working knowledge of GAMP5, GLP, GCP, GMP guidelines especially in the area of computer or related systems. Experience in preparation and review of validation protocols IQ/OQ/PQ documentation, VP, VSR, SOP's, protocol deviation, risk assessment, decommissioning report, periodic review report, Experience in reviewing all SDLC documents, protocols and SOP's and ensure to meet GxP and FDA regulations Experience in developing and reviewing URS, FRA, IRA, FS, CS, DS and TMD'sgood experience in Gap Analysis and documenting remediation planexcellent knowledge and experience in GDPDemonstrated capability to quickly gain a detailed understanding of a process in order to optimize efficiencies and improve qualityExcellent experience in applying FDA regulations to aspects of computer system and Lab systems.HPALM, Valgenesis , SailPoint IDN, Qdoccs, ServiceNow, SAP, Trackwise, QADMS, ITSM, Sailpoint, SciMax MI -Veeva Vault integration , Power BI,DataVision, JIRA, IDEAGEN PleaseReview, IBM Watson(AI Chatbot), Eclipse IDEKnowledge in SQL ,Python, JAVA and VS studio for generating query reports ,automating test scripts and tool building