Our client, is a Biotech company, is looking for a Senior Computer System Validation Consultant (GxP) for their San Diego, CA location.

 

Responsibilities:

• Lead the enhancement and maintenance of the site's Computer System Validation (CSV) program, providing critical Quality Assurance oversight and technical validation expertise for all computerized systems.


• Reporting directly to the Site Quality Head, you will ensure that all IT and automated systems—ranging from laboratory and manufacturing to quality support—are implemented, validated, and maintained in full compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 standards.


• You will act as the Quality Lead for project teams, guiding validation activities throughout the system lifecycle and ensuring inspection readiness for all computerized systems.

Validation Lifecycle & Governance

• Deliverable Management: Auth...