Manager, CSV Audit

Summary: The role of CSV Audit Manager involves leading the development and execution of the Global CSV Audit Strategy and Plan within a global team for a 12-month contract. The position requires collaboration with the CSV Audit Lead and Head of Global Quality Management to establish risk standards and audit methodologies. The role also emphasizes continuous improvement and documentation of the company's Quality System while supporting various audit processes and regulatory inspections. Candidates should possess relevant experience in IT, pharmaceuticals, or medical devices, particularly in Quality Assurance and Computerised System Validation.

Key Responsibilities:

• Support the development, implementation, continuous improvement and documentation of Companies’ Quality System
• Support inspections
• Support the audit process
• Support Regulatory Intelligence
• Support the management of the global, regional and local Standard Operating Procedures (SOPs) and Working Practices (WPs)
• Support the validated state of computerised systems
• Provide advice and act as project liaison

Key Skills:

• Degree in natural science or equivalent business experience
• Several years of Information Technology (IT) industry/pharmaceutical industry/medical devices industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Assurance for Manufacturing, Pharmacovigilance and Clinical Development and Computerised System Validation and Data Integrity
• Qualification as an auditor

Salary (Rate): £85,000.00 yearly

City: Slough

Country: United Kingdom

Working Arrangements: hybrid

IR35 Status: outside IR35

Seniority Level: Mid-Level

Industry: IT