CSV Consultant (Computerized System Validation) – TCS

Responsibilities

• 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 stakeholders 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 finalise review reports

Requirements

• CSV
• FDA regulations 21 CFR Part 11 (Electronic Record...