We are looking for a structured and detail oriented CSV Specialist to support regulated operations within a temporary project assignment in Marburg, Germany. In this role, you ensure that computerized systems are validated according to regulatory requirements and internal quality standards. You play a key role in safeguarding data integrity, compliance and operational excellence across IT and business systems.
Key Responsibilities
• Plan, execute and document Computer System Validation activities according to GxP and relevant guidelines
• Create and maintain validation documents such as URS, FRS, risk assessments, test plans, test cases and validation reports
• Review and approve system changes, ensuring continued validated status
• Support audits and inspections by preparing documentation and providing expert input
• Collaborate with IT, Quality Assurance and business stakeholders on system implementations and improvements
• Ensure compliance with applicable regulations such as GAMP 5, FDA 21 CFR Part 11 and EU Annex 11
• Maintain CSV documentation in line with internal procedures and quality standards