CSV Consultant (Computerized System Validation) – TCS

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 validation deliverables, including Requirements Specifications (URS/FS), Test Protocols, and Final Reports.
• Provide Quality support for the 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.
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