CSV Senior Compliance Advisor

Key Responsibilities: The CSV Senior Compliance Advisor will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for new or revised computerized systems and that these systems are defensible during an inspection and fit for purpose by meeting user requirements.

Responsibilities

• Evaluate proposed new computerized systems or software to assess GxP impact and provide guidance on the risk-based validation approach.
• Work closely with the Project Manager to ensure all compliance milestones are met during the project lifecycle.
• Oversee and/or assist in the development of validation deliverables including Validation Plans, Test Plans/Protocols/Scripts, Specifications and Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification, System and User Acceptance Testing, Data Migration Plans, Traceability Matrices, Validation Reports, Supplier Assessments, etc.
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