IT Compliance Specialist

3 weeks ago


Bengaluru, Karnataka, India Novo Nordisk AS Full time

About the Role

We are seeking an IT Compliance Specialist to join our Site Collaboration Solutions team at Novo Nordisk A/S. As an IT Compliance Specialist, you will be responsible for ensuring that our IT systems meet regulatory requirements and are validated in line with our Quality Management System.

Key Responsibilities

  1. Perform computer system validation (CSV) and computer software assurance (CSA) activities in line with our QMS.
  2. Participate in audits and inspections, identifying and implementing solutions to compliance gaps.
  3. Manage yearly periodic review reports, update audit readiness checklists, and maintain system-level documentation.
  4. Develop and execute release plans, driving all release-related activities.
  5. Define test strategies, manage test execution, review, and report in line with the Software Testing Life Cycle (STLC).
  6. Develop and execute a risk-based validation strategy, acting as a subject matter expert for validation activities.

Requirements

  1. Bachelor's or Master's degree in a relevant field, with a minimum of 8-10 years of experience in the IT industry and 4+ years of GxP validation and CSV/testing experience.
  2. Experience in risk assessment, test management tools, supplier assessment, deviation handling, change management, and GAMP 5 and regulatory requirements.
  3. Expertise in performing complex validation activities, representing Novo Nordisk in relations with users and external stakeholders.
  4. Experience in Agile methodology, Azure DevOps, and automated test management tools.
  5. Excellent interpersonal and communication skills, representing Novo Nordisk in relations with users and external stakeholders.
  6. Minimum 5+ years of experience in performing RCAs, CAPA, and other relevant IT quality assurance activities.

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