Computerized System Validation

CSV Consultant (Computerized System Validation)

Seeking a consultant with experience in Computerized System Validation (CSV) to support regulatory and quality compliance across IT systems.

Mandatory Skills

• CSV
• FDA regulations 21 CFR Part 11, 21 CFR Part 820, GxP Regulations, GAMP 5, SOX Regulations, EU Annex 11, EU Annex 22, ISO 9001, ITIL processes
• Experience with document management tools such as Valgenesis, Veeva Vault

Key Responsibilities

• Collaborate with IT stakeholders to conduct regulatory risk assessments 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 record...