6.8 years of experience in computer system validation related to Lifescience & manufacturing & IT infrastructure, Global Regulatory Affairs, Clinical & Quality Compliance domain and Industrial Automation. •Involved in various systems/ projects end to end validation activities.•Good knowledge on Service now,Agile,Jira,Confluence,X-ray, HP ALM, 21 CFR Part 11, EU Annex11, SDLC, GAMP5, Veeva Vault, Document management system l, Data integrity & ISA 88.•Hands-on experience in Rockwell, Siemens & Mitsubishi, Emerson application DCS, SCADA & HMI development and validations.•Experienced in creation and review of validation deliverables such as Detailed system profile, User requirements Specification (URS), RA, validation plan, Release plan, GxP & Vendor Assessment, Functional Specification, Configuration Specification, Design Specification, Traceability Matrix, SIT, UAT, IQ/OQ/PQ, Release Report, Validation Report and other associated documentation for systems throughout the validation life cycle for both in projects & Operation phases.•performed Risk assessment and involved in creation of Validation plans & summery reports.•Provided an independent review of change control impacted documents to ensure that they meet the regulatory expectations and standards.Well versed in using testing tools like HP ALM, X-ray and having hands-on experience in development, testing and execution of Rockwell, Mitsubishi, Siemens and Emerson Applications.•Coordinated with stakeholders & authored periodic reviews and user access review reports for GMP/ Non-GMP applications.•Strong experience in review of IT service management controls for GxP/ Business critical applications.•Worked on ERP - SAP, SAAS, DCS, MES, IT infrastructure, SCADA, HMI and PLC based validation projects in Lifescience.