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Technical Business Analyst
Project Manager at Cognizant who delivered CARA RIMS go-lives with 99%+ availability and zero audit findings.
IndiaTechnical Business Analyst at Gilead
Gathered and documented business requirements for Veeva Vault RIM, conducted gap analyses, and prepared UAT and validation documentation for GxP-regulated systems.
Veeva Vault RIM SuiteGap AnalysisUATIQ OQ PQ ValidationGxPCI CD
Led regulatory IT projects for life sciences clients, including CARA RIMS and Documentum implementations, validation cycles, and multi-region go-lives.
RIMSDocumentumRIM SystemsVeeva Vault RIM SuiteIQ OQ PQ ValidationFDA 21 CFR Part 11
Pursued a Master of Science in Software Engineering from Vellore Institute of Technology, Vellore, from 2002 to 2007.
Pursued a Master of Science in Software Engineering from Vellore Institute of Technology, Vellore, from 2002 to 2007.
Led RIMsys operations, change management, and ITSM across 10+ markets for Philips's global Go-Live program, coordinating cross-functional teams and ensuring timely delivery.
RIM SystemsWindchillGrafanaChange ManagementITSMSDDDesign SpecificationSCRsIQ+
Architected end-to-end CARA RIMS configuration and application operations, defined project governance frameworks, and led multi-disciplinary teams through implementation and hypercare phases.
RIMSProject GovernanceIQ OQ PQ ValidationHyperCareRisk ManagementStakeholder ManagementDocumentationValidation
Directed Agile software delivery for a 10-member team, running Scrum ceremonies and building PMO artefacts to provide real-time delivery visibility to executives.
AgileScrumPMORAIDVelocity TrackingResource AllocationRisk MitigationSprint Planning
Delivered L2/L3 support for regulatory applications, administered Documentum and FirstDoc environments, and authored SOPs for change control and release management.
DocumentumFirstDocISI PublisherISI WriterFDA 21 CFR Part 11eCTDWebtopSAP IntegrationSolarisSOP DevelopmentChange ControlRelease ManagementL2 L3 Support
Delivered L2/L3 application support for Baxter Healthcare's Regulatory Affairs suite, administered Documentum and FirstDoc environments, and collaborated with vendors for tool integration and patch management.
DocumentumFirstDocISI PublisherISI WriterFDA 21 CFR Part 11eCTDL2 L3 SupportVendor ManagementPatch Management
Engineered DA pre-caching strategies to cut document retrieval query response times by 40% and architected technical design documents for Documentum-based solutions.
DocumentumDA Pre CachingTechnical DesignSolutions Architect
Customized Webtop modules and integrated SAP with Documentum for archival workflows, deployed Documentum clusters and Solaris zones, and managed sandbox and QA environments for BOCS deployments.
WebtopSAP IntegrationDocumentumSolarisBOCSQASandboxChange ControlSOP Development
Profile sourced from Himalayas.