Found Description
CSV Consultant (Computerized System Validation)
In this role you will:
- Collaborate with IT stakeholders to conduct 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 for regulated solutions.
- Guide IT stakeholders on Documents and Records Management.
- Provide recommendations to close compliance gaps and improve processes.
- Ensure compliance to SOPs, policies and procedures.
- Conduct and coordinate periodic review of GxP applications.
- Perform Access Roster review, Audit Trail review processes and finalize review reports.
Requirements:
- CSV certification.
- Knowledge of FDA regulations 21 CFR Part...