Sanquin is currently looking for a Computer System Validation (CSV) Engineer for the ICT department. The primary responsibility will be to coordinate risk-based CSV activities in compliance with FDA / GxP. The role includes the validation of new applications or changes, conducting remediation activities to bring the existing computer systems compliant with industry best practices and guidelines. The job also includes performing periodic reviews to confirm the validation status of applications. Part of the role will include improving the CSV policy and procedures based on industry best practices and guidelines. You will participate in all projects with ICT components (Sanquin wide), interact with all the DevOps teams within ICT as well as with most other ICT teams. The three core values for Sanquin ICT are customer-focus, professionalism and enthusiasm.
Responsibilities include but are not limited to:
- Coordinate the development, implementation, execution and adherence to procedures and methods related to CSV
- Preparation, review and issuing of CSV documents as they relate to computer systems. Coordinate the approval of the CSV documents
- Together with the project leader or application manager, coordinate the integration and UAT testing
- Recommend to QA ICT acceptance of the computer system, as determined from the CSV tasks performed on the system
- Organize and maintain validation documentation
- Improving the CSV policy and methodology in consultation with the ICT and divisional QA teams in accordance with applicable Quality/Regulatory requirements and industry best practices
- Represent CSV in cross-functional team meetings/projects as required
- Prepare CSV documents for audits conducted on ICT activities, support QA in implementing audit recommendations.