I am a passionate and proficient in CSV Validation and IT GxP Compliance , Cloud Validation, Software Validation & Verification, Test Management, where I apply my dynamic experience in regulated GxP computer system validation in the life sciences industries. I have been working in this field for over 8 + years, and I have gained valuable skills and knowledge in CSV Validation, Quality and Compliance Management, Risk Management , Test Management, Defect Management , CAPA, Operational and release management, Gap analysis, and Regulatory Compliance. I worked with various stakeholders on Global IT projects in the pharmaceutical industry, Computer System Validation, ensuring quality and compliance in IT-GxP projects and reviewing and authorizing SDLC validation deliverables. I am well-versed in the implementation of Global IT systems such as SAP HANA S4, SAP ECC 6.0, LIMS, D2-Documentum, eTMF, CTMS, Veeva Vault, IRMS, CARA, and Service Now. I have great exposure to tools like HP ALM, q-test, Devops ,JIRA and TOSCA I also have experience in cloud computing, SaaS validation, and IT infrastructure qualification. My mission is to deliver E2E CSV validation, IT- Compliance and reliable solutions for GxP projects in the life sciences industry, meeting the standards of FDA 21 CFR Part 11, Part 820, NIST, Annex 11, GAMP, and ICH Q9.