1.Prepare and review all CSV documents related to software/application.2.Develop and execute validation documents (Validation Plan, System requirement specification, Risk Assessment Installation Qualification, Operational Qualification and Performance Qualification etc.)3.Author key validation deliverables like Validation Plan, Test Plans, Summary Reports, etc.4.To perform GxP analysis and Gap assessment and its mitigation actions.5.IT QMS handling, CAPA deviation and Change Control management, handle administration of site-specific applications in QC, Manufacturing and Engineering.6.Ensure the execution of all processes complies with various worldwide regulationsi.e. GAMP 5, 21CFR part 11, EU Annexure 11.7.Assist in 21 CFR Part 11 Assessment.8.Perform Backup and Restoration for site specific application in QC, Manufacturing and Engineering (whenever required)9.Understand and adhere to the Quality manual, SOP on Project Management, Change Management, Document Management, and Quality Management.10. Responsible to Prepare & Review Standard Operating Procedures/relevantdocuments.