Pravin Katkar

About Pravin Katkar

Seasoned IT CSV professional with multi-year experience in Pharmaceutical and IT…

Experience

1. Csv Lead, Quality Specialist

   LTIMindtree

   Dec 2020 — Present · Pune, IN

   Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like Oracle JDE, SAP, LIMS, MES, TrackWise, Veeva Vault, ValGenesis, etc. Perform GAP analysis, Risk Assessment using FMEA model, implement Quality Risk Management Systems to define validation strategy, prepare risk scenario and RPN evaluation, identifies critical control points, determine degree of testing required, define test procedure and acceptance criteria on the basis of current controls verified from functional and design specification. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers and Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Review status updates and prepare management presentations. Author, Review and Approval of key CSV deliverables like Validation Project Plan, Test Plan, HLRA, RA, URS, FRS, SRS, VP, DS, RTM, IQ, OQ, PQ, UAT, Periodic Review Report, SOP etc. Handling of technical change control, assessment of deviations and investigation management through quality management system.

Education

• MSBTE

  Diploma engineering

• Kalinga University, Raipur

  B. Tech