Job Description
**Summary**:
The Audit and Compliance Specialist is responsible for the compliance and Quality Assurance support of the GxP computerized systems including supplier quality assessment/management throughout their lifecycles in regards to the applicable regulations and requirements defined in the Novartis Quality Manual and procedures.
eCompliance provides guidance on CSV related topics and related information.
- Reviews and/or approves the qualification and operational deliverables of respective GxP computerized systems.
Managing work in accordance with the law, internal regulations, good practices and business objectives.
**About the Role**:
**Major Accountabilities**:
- Ensure all site activities comply with cGxP, regulatory requirements, company quality standards, and data integrity expectations.
- Plan, support, review, and approve key quality activities including PQR/APQR, validation, qualification, change controls, CAPAs, deviations, and follow-up...
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