CSV Subject Matter Expert

SUMMIT RECRUITMENT AG seeks a Senior CSV Subject Matter Expert in Basel to manage validation activities for production and IT systems, ensuring GAMP 5 compliance and data integrity.

This position focuses on executing Computerized System Validation (CSV) tasks within Production, Quality Control, and IT environments. The primary objective is to maintain strict adherence to GAMP 5 standards while safeguarding data integrity across critical systems.

Responsibilities

• Execute CSV procedures for Production, Quality Control, and IT platforms including LIMS, ERP, and eQMS.
• Ensure all activities comply with GAMP 5 guidelines and uphold high standards of data integrity.
• Manage and carry out validation stages such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support audit preparation, troubleshoot issues, and drive process improvements.

Requirements

• Minimum of 8 years of practical CSV experience in pharmaceutical or laboratory settings.
• Strong knowledge of GAMP 5, cloud infrastructure, and data integrity principles.
• Fluency in both English and German.
• Proven experience with ERP, MES, SCADA, LIMS systems, and agile methodologies.

Nice to have

• Ability to communicate in French.