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Position Overview
The CSV Senior Compliance Advisor plays a key role in ensuring that IT-managed GxP computerized systems and infrastructure are validated or qualified in line with corporate quality standards and applicable regulatory requirements. This role oversees GxP-impacting projects for new or revised computerized systems, helping to ensure solutions are inspection-ready, compliant, fit for purpose, and aligned with user requirements.
Key Responsibilities:
Implementation Projects
Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provides guidance on the risk-based validation approach for the system
Work closely with the Project manager to ensure all compliance milestones are met during the project lifecycle.
Oversee and/or assists in the development of validation deliverables including Validation Plans, Test Plans/Protocols/Scripts, Spec...