Shyam Kawarkhe

Senior Associate Consultant @Infosys

Pune, IN

Developed and implemented comprehensive validation strategies and approaches.• Ensured compliance with Computerised System Validation (CSV) at the site in accordance with ISPE GAMP 5, 21 CFR Part 11, EU Annexe 11, ISO 27001, ISO 9001, ISO 14001, and internal procedures.• Validated GAMP Category 5 web-based applications and performed system impact assessments.• Coordinated GxP impact software identification, categorisation, and qualification in line with GAMP guidelines to meet regulatory requirements.• Conducted Quality Risk Assessments for gaps identified during software implementation, reducing compliance gaps by 20%.• Coordinated and executed test scripts according to detailed strategies and plans.• Reviewed and approved System Change Requests (SCR), Quality System Impact Assessments (QSIA), GxP Assessments, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Functional Risk Assessments (FRA), Design Specifications (DS), Maintenance Plans, Test Summary Reports, Traceability Matrices (TM), and Validation Summary Reports (VSR).• Prepared Validation Plans (VP) and Validation Summary Reports (VSR).• Supervised multiple projects simultaneously, consistently meeting or surpassing deadlines.• Documented test results, promptly addressed issues, and managed deviations from the test plan.• Maintained and updated documentation, templates, procedures, and SOPs with accuracy.• Conducted Quality Review Meetings and provided updates to senior management on CSV and IT compliance progress.• Conducted Quality Review Meetings and provided updates to senior management on CSV and IT compliance progress.• Led validation change request–driven CSA approach, reducing redundant documentation and improving efficiency.

Sant Gadge Baba Amravati University, Amravati

Bachelor of Electrical Electronics and power engineering

Dr. D. Y. Patil Institute of Technology, Pimpri, Pune

Master of Business Administration - MBA