IT Validation and Compliance Specialist I

2 weeks ago

Bengaluru, Karnataka, India Novo Nordisk Full time

Job Summary

As an IT Validation and Compliance Specialist I 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
  • Defining a risk-based validation strategy and executing it in line with QMS
  • Acting as an SME for Validation activities and executing the validation strategy in Agile and V Model as necessary
  • Defining test strategy, managing test execution, reviewing, and reporting in line with Software Testing Life Cycle (STLC)
  • Handling validation deviations, performing CAPA and RCA using 5 x Why approach or similar
  • Participating in audits and inspections, finding solutions to compliance gaps identified
  • Providing compliance consulting for IT activities
  • End-to-end service delivery management of assigned/owned services
  • Performing stakeholder management as part of delivering services involving multiple stakeholders

Qualifications

  • Bachelor's or Master's degree in a relevant field with minimum 6+ years of experience in a service-based organization/pharmaceutical industry, preferably in the IT quality domain
  • Industry-recognized ITIL and ISO quality management certification
  • Minimum 4 years of practical experience in GxP areas with exposure to regulatory affairs and 2+ years in performing Root Cause Analyst (RCA), CAPA, and other relevant IT quality activities
  • Experience in Risk assessment (IT RA, Quality, Functional, DI, Supplier) and exposure to Test management tools such as HP ALM
  • Experience with both waterfall and Agile methodology, supplier assessment, deviation handling, change management
  • Good understanding of GAMP 5 and various Regulatory requirements including CFR part 11, EU Annex 11

About Novo Nordisk

Novo Nordisk is a leading global healthcare company with a legacy of driving change to defeat serious chronic diseases. We are growing massively and expanding our commitment, reaching millions around the world, and impacting more than 40 million patient lives daily. Our success relies on the joint potential and collaboration of our employees around the world.

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