Durga Yadav

Background

About Durga Yadav

A dedicated, keen, enthusiast CSV and Quality Professional with 7 years' experience in pharmaceuticals. Proven ability to manage projects and adhere to regulatory guidelines. Skilled in Validation (Process & IT systems) activities, CSV documentation, and QMS.Extensive expertise in Periodic Review, Risk assessment, CAPA,Defect, GAMP 5, 21 CFR Part 11, EU Annex 11, CSV lifecycle,Supplier Management. Versatile experience across Injectable, OSD,Biologic's, sterile Injectable, Excipients, and APIs, with proficiency in various qualification approach in the green field and Brown Field Projects Application like HP ALM, Service Now, Veeva Vault,IT/OT system, Laboratory instrument. Key Responsibilities-Validation Deliverables: Specialist in developing and managing comprehensive validation documentation, including Validation Plans, Risk Analysis, Test Protocols and Reports, Test Executions, Defect, Validation Reports, Traceability Matrix,Periodic Evaluation and SOPs-CSV Strategy: Leading the implementation of CSV processes across various systems to ensure compliance with regulatory standards and industry best practices. Also have worked with CSA approach in software development-System Expertise: Validation of a wide range of systems and applications manufacturing, and analytical systems-Regulatory Guidance: Ensuring all validation activities align with current regulatory requirements-Quality Management Systems: Extensive knowledge of quality management processes within the pharmaceutical industry, including handling deviations, CAPAs, change controls, and overall quality management systems (QMS). Core Competencies-Computerized System Validation (CSV)-Validation Strategy and Implementation -Regulatory Compliance -Periodic Evaluation, ERP, Risk Assessment, MES, Trackwise, HP ALM, Veeva Vault,Service now, and IT/OT Systems -Quality Management (Deviation, Change Management, Defect, CAPA) in the Pharmaceutical Industry