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IT Validation Specialist

1 month ago

Bengaluru, Karnataka, India Novo Nordisk Full time

About the Role

As an IT Validation Specialist at Novo Nordisk, you will be responsible for performing activities related to Computer System Validation (CSV) and Computer Software Assurance (CSA) in line with the company's Quality Management System (QMS). This includes validation for GxP Computerized Systems and Computerized Equipment in both project and operations phases.

Key Responsibilities

  • Performing CSV and CSA activities in line with QMS
  • Service Management responsibility for multiple projects
  • Participating in audits and inspections, including finding solutions to compliance gaps
  • Managing yearly periodic review reports and audit readiness checklists
  • Defining test strategy, managing test execution, and reviewing and reporting in line with Software Testing Life Cycle (STLC)
  • Performing CAPA and RCA using the 5 Whys approach
  • Defining a risk-based validation strategy and executing it in line with QMS

Requirements

  • Bachelor's or Master's degree in a relevant field
  • Minimum 8-10 years of experience in the IT industry, with a minimum of 4 years of GxP Validation and CSV experience
  • Experience in risk assessment and test management tools such as HP ALM
  • Good understanding of GAMP 5 and various regulatory requirements
  • Expertise in performing validation activities for complex projects

About Novo Nordisk

Novo Nordisk is a leading global healthcare company with a legacy of driving change to defeat serious chronic diseases. We are committed to improving the lives of millions of people around the world and impacting more than 40 million patient lives daily.