CSV Specialist

We are looking for a structured and detail oriented CSV Specialist to support our regulated operations. 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 GAM...