Digital Compliance Expert
2 weeks ago
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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