Pharmaceutical Compliance Expert

1 month ago


Bengaluru, Karnataka, India Novo Nordisk Full time

About the Role

We are seeking a highly skilled Pharmaceutical Compliance Expert to join our team at Novo Nordisk. As a key member of our Digital, Data & IT - Product Supply GBS unit, you will be responsible for ensuring compliance with current industry regulations, guidelines, and trends.

Key Responsibilities

  • Provide expertise in validation and support end-to-end audits and inspections.
  • Drive continuous improvement in product quality and compliance systems.
  • Review and manage validation activities, including review, approval, and authorization of validation deliverables.
  • Lead timely quality system implementation and manage processes to ensure compliance and quality.

Requirements

  • Bachelor's degree in Electronics and Communication or relevant field.
  • 10+ years of experience in IT and relevant experience in Software Testing Lifecycle and Computer System Validation (CSV) across life sciences and healthcare domains.
  • Excellent communication skills and ability to represent Novo Nordisk in relations with users and external stakeholders.
  • Expertise in test delivery management, QMS, SQA activities, process assessments, testing activities, 21 CFR 11, 21 CFR 820 regulatory requirements, GxP compliance, and good documentation practices.

About Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. We are committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and communities we operate in.



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