What You'll Be Doing

• Leading Computer System Validation (CSV) activities throughout the system lifecycle
• Developing validation strategies and documentation in accordance with GAMP® 5 (2nd Edition)
• Supporting implementation and validation of regulated IT systems including ERP, LIMS, MES, Veeva Vault, eQMS and Document Management Systems
• Performing GxP risk assessments and supplier assessments
• Supporting audit and inspection readiness activities
• Collaborating with business, IT, quality and external vendors across international project teams
• Advising clients on best practices for Computer System Validation and Computer System Assurance (CSA)

What we’re looking for

Minimum 5 years of experience in Computer System Validation (CSV) within the pharmaceutical, biotechnology or medical device industry.

Strong understanding of GAMP® 5, EU Annex 11, 21 CFR Part 11 and GxP requiremen...