Computer System Validation Engineer

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

As a quality and compliance expert, you will be responsible for ensuring that GxP systems and processes adhere to the applicable regulatory requirements throughout the entire system lifecycle. Therefore, you stay up to date about evolving regulations from authorities such as the EMA and FDA and industry standards like GAMP and ISO. Depending on your role and expertise, you may be asked to provide Quality & Compliance support during audits and inspections, or to join a Sopra Steria validation service team.

As a trusted Computerized System Validation (CSV) Engineer, you play a key role in the validation process of the computerized systems used by our clients in the Life Sciences sector. More specifically, your mission is to ensure the quality and regulatory compliance of GxP systems throughout their entire life cycle and across all GxP areas (GLP, GCP, GMP, GDP, GPvP). Systems in scope can include site-specific lab instruments (e.g. HPLC software) and production equipment (e.g. capsule filling machine), but also globally used web applications, Clinical Trial Management Systems, complex Manufacturing Execution Systems, SAP systems, medical devices, etc...