Ganesh Shantaram Pagar
Executive - IT Qa and Csv Compliance @Glenmark Pharmaceuticals
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WORK HISTORY
Executive - IT Qa and Csv Compliance @Glenmark Pharmaceuticals
Actively involved in the implementation, validation, and review of deliverables for L2 Data Acquisition Systems (DAS) and MES – Werum PAS-X.Oversee and support implementation, validation, and lifecycle management of GxP computerized systems across Manufacturing and Laboratory environments. Provide quality oversight on CSV activities, IT documentation, QMS, data backup/restore, and ensure compliance with regulatory standards, internal IT policies, and site procedures through audits and quality reviews.Review CSV lifecycle documentation for regulatory alignment, conduct system assessments during implementation and maintenance, and perform risk and impact analysis for system changes. Collaborate with project managers to identify risks and implement mitigation strategies.Support internal and external audits by providing compliance evidence and explaining validation and IT processes. Perform supplier assessments, periodic system reviews, audit trail checks, and routine audits to identify gaps and improvement opportunities.Collaborate with QA, IT, and vendors to close audit findings and implement CAPAs. Review SOPs, coordinate training, assign LMS modules, and track training compliance. Initiate, review, and close QMS events related to GxP systems.Ensure adherence to Data Integrity principles and Good Documentation Practices while driving continuous improvement across IT quality and compliance functions
EDUCATION
Savitribai Phule Pune University
Bachelor of Pharmacy , Pharmacy, Pharmaceutical Sciences.
K V N Naik College of Arts, Commers And Sciences, Canada Corner, Nashik
Higher Secondory Education , 11th And 12th Science
ABOUT GANESH SHANTARAM PAGAR
Dynamic and detail-oriented pharmaceutical professional with 7+ years of experience specializing in Computer System Validation (CSV), compliance, Quality Assurance and Manufacturing within the pharmaceutical sector. Adept at managing end-to-end validation projects, ensuring adherence to global regulatory standards including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Skilled in cross-functional collaboration, documentation, and regulatory audits (USFDA, MHRA, WHO). Strong expertise in risk assessment, change control, and CAPA processes, with a proven track record of enhancing operational efficiency and compliance. Seeking opportunities to contribute to organizational excellence through innovative problem-solving and robust validation practices.
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