My client is seeking an experienced CSV Audit Manager to join their global team on a 12 month contract. Excellent salary and benefits including bonus and hybrid working/
The main task is the development and execution of the Global CSV Audit Strategy and Global CSV Audit Plan in close collaboration with the CSV Audit Lead and the Head of Global Quality Management. This includes defining risk standards and methodologies, audit methodology and best practices to ensure consistency of approach.
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)
Provide advice and act as project liaison
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