Manager, CSV Audit

JR United Kingdom; Reading; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading company is seeking an experienced CSV Audit Manager for a 12-month contract. In this role, you will develop and execute the Global Audit Strategy while ensuring compliance within the pharmaceutical industry. You will support quality systems, audits, and inspections, and collaborate closely with management to define best practices. Ideal candidates will have a relevant degree and extensive experience in quality assurance and computerized systems.

Benefits

Excellent salary and benefits including bonus

Qualifications

• Several years of relevant experience in IT, pharmaceuticals, or regulatory authorities.
• Preferably includes Quality Assurance experience.

Responsibilities

• Develop and execute Global CSV Audit Strategy and Plan.
• Support audit processes and maintain global SOPs and WPs.
• Ensure the validated state of computerized systems.

Skills

Quality Assurance for Manufacturing

Pharmacovigilance

Clinical Development

Computerised System Validation

Data Integrity

Education

Degree in natural science or equivalent

Job description

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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 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