GxP CSV Engineer – Life Sciences Compliance

Editx; Diegem; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Editx is seeking a quality and compliance expert to ensure GxP systems and processes meet EMA, FDA, and industry standards across the full lifecycle. You will stay current with evolving regulations and support audits and inspections within a Life Sciences validation context.

As a trusted CSV Engineer, you will contribute to validation activities for computerized systems used in GMP/GLP/GCP environments and collaborate with teams to ensure regulatory compliance across diverse systems and

Responsabilités

• Ensure GxP systems and processes adhere to regulatory requirements throughout the system lifecycle.
• Stay up to date on evolving regulations from authorities such as EMA and FDA and industry standards like GAMP and ISO.
• Provide Quality & Compliance support during audits and inspections, or join a Sopra Steria validation service team.

Description du poste

Editx is seeking a quality and compliance expert to ensure GxP systems and processes meet EMA, FDA, and industry standards across the full lifecycle. You will stay current with evolving regulations and support audits and inspections within a Life Sciences validation context.

As a trusted CSV Engineer, you will contribute to validation activities for computerized systems used in GMP/GLP/GCP environments and collaborate with teams to ensure regulatory compliance across diverse systems and