IT Validation Specialist

1 week ago


Bengaluru, Karnataka, India Novo Nordisk Full time

About the Role

As an IT Validation & Compliance 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, both in the project and operations phase.

Key Responsibilities

  • Service Management responsibility for multiple projects.
  • Participate in audits and inspections, including finding solutions to compliance gaps identified in audit/inspections.
  • Managing yearly periodic review reports, upkeeping audit readiness checklist, and all system level documentation.

Requirements

  • Bachelor's or Master's degree in a relevant field.
  • Minimum 8-10 years of experience in the IT industry and 4+ years of GxP Validation and CSV/Testing experience.
  • Experience in Risk assessment and Test management tools.
  • Good understanding of GAMP 5 and various Regulatory requirements.

About Novo Nordisk

Novo Nordisk is a leading global healthcare company with a legacy of driving change to defeat serious chronic diseases. Our success relies on the joint potential and collaboration of our employees around the world.



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