Digital Compliance Expert

2 weeks ago


Mumbai, Maharashtra, India Teva Pharmaceuticals Full time

About the role

We're seeking a highly skilled Digital Compliance Expert to join our team at Teva Pharmaceuticals. As a key member of our quality assurance department, you will play a critical role in ensuring that our IT systems comply with global regulations.

Key responsibilities

  • Continuously improve TAPI cGxP Computerized Systems policies, standards, procedures, tools, and training.
  • Manage site inspection readiness and support for globally managed Computerized Systems.
  • Guide TAPI Sites IT and IT QA on inspections trends, observations, authorities' expectations, and best practices to mitigate gaps.
  • Deliver training programs to TAPI Computerized systems owners.
  • Support sites with any IT-related project(s) as required.
  • Support sites in computer systems validation, infrastructure qualification, and systems life cycle management, together with any remediation needed.
  • Conduct GxP computerized systems gap assessments/evaluations with applicable regulations.
  • Provide QA IT review and approval on all globally managed Computerized System deliverables.
  • For some globally managed Computerized Systems, provide QA IT review and approval on the System deliverables, and for others, represent site users, as System Business Owner.

Requirements

  • BE/B.Tech in Information Technology
  • 10 to 15 years of experience


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