Found Description
CSV Consultant (Computerized System Validation)
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 stakeholder 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 review of GxP applications
- Conduct Access Roster review, Audit Trail review processes and finalize review reports
We have some requirements:
- CSV
- FDA regulations 21 CFR Part 11 (Electronic Records and E...