Computerized System Validation
Location
Remote, Remote
Job Type
Full-time
Category
Other-General
Posted
June 07, 2026
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...