Pooja Bhanudas Dokhe
Csv Csa & Data Integrity Specialist @PQE Group
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WORK HISTORY
Csv Csa & Data Integrity Specialist @PQE Group
Rome, IT
Oversee multiple parallel validation projects for global pharmaceutical clients, providing expert support and resolving issues.2. Analyze client requirements, gather data, and implement optimal solutions for validation and compliance challenges.3. Prepare and review CSV documentation, including Validation Plans, URS, Risk Analyses, Testing Protocols, Test Reports, IQ, OQ, PQ, Traceability Matrix, and Validation Reports.4. Perform Computerized System Validation (CSV) for GxP systems in compliance with GAMP 5, producing essential deliverables such as VP, URS, FRS, DS, IQ, OQ, PQ, and VSR.5. Manage project execution using SDLC models (V, Waterfall, Agile), conducting manual and automated testing with comprehensive Test Plans, Methodologies, and Scripts.6. Leverage tools like JIRA, Confluence, Veeva Vault, HP ALM, and qTest for project management and validation testing.7. Lead on-site testing efforts and oversee test execution within HP ALM.8. Manage validation documentation and compliance reviews within Veeva Vault.9. Conduct periodic reviews, issue SOPs, and ensure compliance with regulatory standards (FDA, 21 CFR Part 11, EU GMP Annex 11).10. Ensure compliance with ALCOA+ Data Integrity principles and GAMP 5 standards throughout validation processes.
EDUCATION
Deogiri Institute of Engineering and Management Studies, Aurangabad
Bachelor in Business Administration, Business/Managerial Economics
Università degli Studi di Cassino e del Lazio Meridionale
Master's degree, Business, Management, Marketing, and Related Support Services
ABOUT POOJA BHANUDAS DOKHE
Proudly hold a Master\'s degree in Global Economy and Business.Experienced Data Integrity Specialist at PQE Group with expertise in GAMP 21, ALCOA+, and System Validation. Skilled in VEEVA Engage, HP ALM, Jira, Confluence, and 21 CFR Part 11 compliance. Former Research Assistant specializing in Economics and AI/ML. Proficient in SAP BW/HANA, SQL, BO, and Power BI. Excelled in financial planning and event management. Committed to excellence and seeking collaborative opportunities.
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