Rathnakar Raghunath

About Rathnakar Raghunath

I\'m a result oriented and value-adding professional with over 25 years in IT for products…

Experience

1. Principal Consultant

   Infosys

   Apr 2019 — Present · Bengaluru, IN

   Design, develop, review of QMS procedures with a focus on regulatory compliance and simplicity of use and help in QMS design and improvement• Identify and prioritize automation opportunities for CSV and SQA activities• Conduct Quality Management System Audits• Strategize and lead Computer System Validation for the IT landscape• Elicit and develop requirements for migration of IT systems and data in divestiture and acquisition scenario• Provide training, mentoring and coaching in- Setting up Quality Management Systems for development, validation and operation & maintenance of GxP IT Systems and Infrastructure - Tailoring of Software Development Life Cycle with special focus on quality gates - IT system regulations for GxP system development (21 CFR Part 11, EU Annex 11)- Soft skills

Education

• Birla Institute of Technology and Science, Pilani

  M.S.

  2007 — 2010

• Bangalore University

  B.E.

  1995 — 1999

Skills

• Quality Assurance
• Requirements Analysis
• Validation
• Gap Analysis
• Quality System
• Test Management
• Manual Testing
• I/T Gxp Audits
• Quality Management
• Pre-Sales
• Cmmi
• Test Automation
• Regression Testing
• Vendor Management
• User Acceptance Testing
• Gamp
• Process Improvement
• Test Cases
• Requirements Gathering
• Iso
• Pharmaceutical Industry
• System Testing
• Testing
• Software Documentation
• Sdlc
• Computer System Validation
• 21 Cfr Part 11
• Software Quality Assurance
• Software Project Management
• Software Engineering
• Test Planning