Rajkumar Mantha

About Rajkumar Mantha

Over 15 years of experience in IT Computer System Validation (CSV) and Quality Assurance in FDA regulated Pharmaceutical, Biotech, Medical device, Clinical, Health care, and Consumer products industries.Expertise in Planning and executing validation activities - Developing and maintaining validation documentation - Conducting risk assessments - Collaborating with cross-functional teams. •Proficient in SDLC, Computer System Validation methodologies and concepts of qualification protocols (IQ/OQ/PQ) to compliance with FDA 21 CFR Part 11, GxP (GMP, GLP, GCP) GDP, and GAMP5 standards. •Performed Validation of cloud-based applications, ERP, TraceLink Serialization, Argus Safety System, TrackWise QMS, Oracle Siebel clinical, CTMS. •Performed Change Risk Assessment (CRA) and System Risk Assessments (SRA) and GxP assessments, ER/ES assessment, Audit trail and Technical Impact assessment. •Authored, review, and approval of Validation Project Plan (VPP), execution of IQ/OQ/PQ, UAT scripts, Validation Summary Reports (VSR) and Requirement Traceability Matrix (RTM). •Pre and post review approval of IQ/OQ/PQ to compliant per Good Documentation Practice (GDP) and Good Testing Practice (GTP) procedures. •Authored Verification phase Strategy and Verification phase summary reports. •Analyzing Business Requirements, DCS (Design and Configuration Specifications) and Developed URS (User requirement Specifications) and FRS (Functional Requirement Specifications). •Developed SOPs, and Work Instructions and Guidance documents. •Proficient in SDLC Methodologies: Waterfall, V model and Agile (Sprint planning and Scrum sessions). •Developed Data Migration deliverables (Plan, Mapping specifications, Test scripts, Summary reports) • Performed verification of Medical Devises on mobile platforms (iOS and Android).•Developed System Implementation Strategy (SIS) and System Release Authorization Notice (SRAN). •Proficient in Test Management Tools: HP ALM Quality Center, JIRA, KNEAT and YouTrack tool.•Developed Deviation/Defect reports on root cause, corrective action, and resolution to close the defects. •Authored Change Plan, Test Plan, test scripts Change summary and Test Summary Reports. Authored System Retirement Plans and Summary Reports.•Document management system: One Vault, CORAL, LIVE Link and EDMS.•Performed System testing, Functional testing, Regression and UAT testing.•Performed Change Control and Change request by using Service Now (SNOW) and KNEAT. •Handled multiple Validation projects and provided validation support in a timely manner.

Experience

1. Gxp IT Quality Assurance & E-compliance

   Bristol Myers Squibb

   Aug 2023 — Present · New Brunswick, NJ, US