Gali Manjula Devi
LIMS Tester/Validation Engineer
About
Testing and Validation professional with 4 years of IT experience in the Life Sciences domain, specializing in Lab Vantage LIMS validation and testing. Strong expertise in Computer System Validation (CSV), FDA GLP, 21 CFR Part 11, and GxP-regulated environments. Hands-on experience with SAP QM, Empower, and Val Genesis, ensuring data integrity, regulatory compliance, and system quality across validated systems. Seeking to leverage expertise in LIMS Testing or validation and regulatory compliance in a challenging role.
Skills & Expertise (23)
Work Experience
LIMS Tester/Validation Engineer
Tata Consultancy Services
Mar 2022 - Apr 2026
Performed functional testing and validation of Lab Vantage LIMS to streamline laboratory processes and improve data management. Analyzed business requirements, conducted impact analysis, and prepared test plans, test cases, and validation documentation. Designed System, Module, Configuration, Validation and UAT test cases as per customer requirements. Prepared and executed URS, FS, DS, IQ, OQ, PQ, and maintained Requirement Traceability Matrix (RTM) to ensure full requirement coverage. Supported regression testing for enhancements and defect fixes to ensure system quality. Conducted risk assessments, re-testing, formal executions and formal verification activities using Val Genesis. Validated audit trails, electronic signatures, user roles, and access controls in compliance with FDA 21 CFR Part 11. Managed Change Management activities, including Change Requests (CRs), impact assessment, stakeholder reviews & approvals, and CR closure. Handled Service Requests (SRs) related to user access management, Department creation, Policy creation & updation, Printer installation & Un-installation activities. Investigated and resolved Incidents, including data discrepancies, workflow failures, access issues, and system defects, ensuring timely root cause analysis and resolution. Coordinated with business users, IT teams, and Lab Vantage support to resolve incidents and implement preventive actions. Ensured proper documentation, testing, and validation evidence for SRs and incident fixes in accordance with validation and compliance requirements. Worked extensively with Lab Vantage LIMS v8.7.1 across multiple modules.
Education
M.Sc. in Computer Science - Sri Krishnadevaraya University
- 2021 · Afghanistan
Certifications
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Skills (23)
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