Senior Technical Consultant – Front Arena

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 stakeholders on documents and records management.
• Recommend actions to close compliance gaps and improve processes.
• Ensure compliance with SOPs, policies and procedures.
• Conduct and coordinate periodic review of GxP applications.
• Conduct access roster review, audit trail review processes and finalize review reports.

Qualifications & Requirements

• Experience with CSV and FDA regulations 21 C...