Job Description
The CSV Senior Compliance Advisor will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems. The role focuses on laboratory equipment and test equipment in the manufacturing area.
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 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 Rep...