A life science consultant having 14+ years of experience in creation, supporting & maintenance of Quality Management Systems. Information Security (ISO 27001), Periodic review, SoX controls, and validation of ERP (SAP)/Non ERP, Clinical IT applications, Cloud apps and Infrastructure services. Have strong expertise in V-Model (including SQA), Agile, GAMP 5, Risk Management, GxP, ER & ES, ITIL (Change, Incident, Problem Management), USP-1058 Analytical Instrument Qualification. Exposure to manage and work closely with client at onsite location. • Kualalumpur (Malaysia)-Jun 2013 to Mar 2015 • Fort Worth (USA): Sep 2016 to Mar 2021 Skill / Experience Summary: • Validation Lead for multiple domains aimed to achieve higher level of compliance both for projects and operational activities assessment following risk-based approach. • Consulted project and application teams with good domain knowledge – Quality and compliance in Pharma industries, Pharmacovigilance, Drug Development, GAMP 5, ER&ES Regulations, GxP and CSV Documentation. • Project Quality Management- IT Process and Validation Consulting, validation activities for complete SDLC Projects, Authoring and Reviewing Validation Plan/Report, Traceability matrix, Risk assessment, system life cycle documents (IQ, OQ, PQ) and Communication. • Production Support Compliance Monitoring as Operational Quality Lead. •Good exposure of handling Audits. Ensured IT compliance through assessments ensuring IT security controls are in place and been implemented in totality. • Deviation and CAPA management • Involved in Vendor Assessment & 3rd party assessment. • Business Analyst– Request for Proposals (RFPs), Requirement gathering & customer interviews. • Trainer– CSV, Operational IT processes (Change, Incident and problem management, RCA, Deviation Management), Risk Assessment, CSA. • Team Manager- Team management, Intra/Inter team reporting, Team review and Appraisals. • Tools: o Change Request Management Tool: SolMan (SAP), RoD, ServiceNow o Incident and Problem Management: ITSM (SAP), ServiceNow o Patient Safety: ARGUS safety, ARISg, SAPPHIRE o Analytical Applications : UV WinLab, Envision, HPLC, EMPOWER, LIMS o Testing: HPALM, qTest o Agile: JIRA, Confluence o Document Management: DocNavigator, SharePoint, DMS SAP, CoreDox o MS office: MS Visio, MS Word, MS Excel, MS PowerPoint, MS Project o Risk: ServiceNow GRC