Hello, I'm Bharat Sonawane, a Computerized System Validation (CSV) and IT Quality professional with 5+ years of experience in the pharmaceutical and life sciences industry. Throughout my career, I have worked on GxP-regulated computerized systems, software validation, IT quality assurance, risk-based validation, and regulatory compliance following GAMP 5, 21 CFR Part 11, and EU GMP Annex 11.
I have hands-on experience with validation documentation, risk assessments, change management, deviations, CAPA, audit readiness, Agile delivery, DevOps quality processes, Jira, Confluence, Xray, and validation lifecycle management.
My mission is to simplify complex CSV concepts into practical, industry-focused learning that helps students confidently start or advance their careers in pharmaceutical validation. My courses are designed with real-world examples, templates, interview guidance, and practical knowledge that can be applied immediately in the workplace.
Whether you are a fresher, pharmacy graduate, quality professional, or IT professional looking to enter the regulated pharmaceutical industry, my courses will provide a clear roadmap to build the right skills and succeed in your career.