shravan kulkarni

12 yrs CSV, GxP ITQA

• Performance driven and result oriented professional offering an experience of 12 years in Computer System Validation, IT Compliance, IT Quality Assurance, Quality Management System, 21 CFR Part11, GxP Assessment, ERES, GAMP5 cat, IT Risk Assessment, Vendor Assessment, Risk Management, Deviation Handling, Change Management, CAPA and Audit Support within Pharmaceutical/Life Science/CRO Industry.
• Excellence in transforming quality function into a robust quality unit that delivers maximum output with zero defects and driving capability improvement of processes, systems & people through implementation of quality pillars.
• Demonstrated extensive proficiency in Computer System Validation (CSV) and IT-QA, with a strong emphasis on regulatory compliance, quality management, and Validated state of the GxP systems.
• Skilled in performing GxP assessment, gap assessments, audit readiness program, preparing inspection readiness checklist, remediation as well as response preparation for inspectional observations.
• Experienced in driving and leading Complex Stakeholder and Business meetings with excellent technical, problem-solving, and compliance skills.
• Possessed a wealth of expertise in documentation, training, and fostering team collaboration, with an unwavering commitment to enhancing organizational efficiency and driving continuous improvement.
• Instrumental in developing and updating validation deliverables and documentation to align with regulatory requirements.

BE/B.Tech in Computer Science