CSV

About the role

As inventive transformation consultants, we blend our strategic, creative and scientific capabilities, collaborating closely with clients to deliver cutting-edge solutions. Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose.

What you'll do

• Lead and support Computer Systems Validation (CSV) activities for GxP-regulated computerized systems throughout the System Development Life Cycle (SDLC)
• Ensure compliance with GxP, FDA 21 CFR Part 11, company SOPs, and Quality Management System (QMS) requirements
• Review, assess, and approve validation deliverables, risk assessments, testing documentation, and change controls
• Collaborate with Business, Quality Assurance, IT, and external vendors to ensure validated and compliant system implementations

What you need

• Compliance
• LLMs
• Bug tracking
• Audit
• SOP writing
• ISO 9001