We are looking for a 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 of validation deliverables, including Requirements Specifications (URS/FS), Test Protocols, and Final Reports
• Provide Quality support for the Projects and Application and Infrastructure changes
• Support of Audit and Inspection Readiness of regulated solutions
• Guiding IT stakeholder on Documents and Records Management
• Providing recommendations to close the existing compliance gaps and improve the processes
• Ensuring compliance to SOPs, policies and procedures
• Conducting and coordinating periodic review of GxP applications
• Conducting Access Roster review, Audit Trial review processes and finalizing review reports
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