Manager, CSV Audit

ZipRecruiter; Slough; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading global company is seeking an experienced CSV Audit Manager for a 12-month contract. You will be pivotal in developing the Global CSV Audit Strategy, supporting quality assurance processes, and ensuring compliance with industry standards. This role offers excellent salary, benefits, and hybrid working conditions.

Qualifications

• Degree in natural science or equivalent business experience.
• Several years of experience in IT/pharmaceutical/medical devices industry.
• Qualification as an auditor.

Responsibilities

• Develop and execute Global CSV Audit Strategy and Audit Plan.
• Support the development and documentation of Quality System.
• Aid in the audit process and regulatory inspections.

Skills

Quality Assurance

Pharmacovigilance

Computerised System Validation

Data Integrity

Regulatory Intelligence

Education

Degree in natural science or equivalent business experience

Job description

Job Description

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.

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

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