In this role you will:

• Collaborate with IT stakeholders for conducting Regulatory Risk Assessment of quality systems, solutions and services
• Review validation deliverables, including Requirements Specifications (URS/FS), Test Protocols, and Final Reports
• Provide quality support for projects and application and infrastructure changes
• Support audit and inspection readiness of regulated solutions
• Guide IT stakeholders on documents and records management
• Provide recommendations to close existing compliance gaps and improve processes
• Ensure compliance to SOPs, policies and procedures
• Conduct and coordinate periodic reviews of GxP applications
• Conduct Access Roster review, Audit Trail review processes and finalize review reports

Requirements:

• CSV experience
• Familiarity with FDA regulations 21 CFR Part 11, 21 CFR Part 820, GxP...