Manager, CSV Audit

JR United Kingdom; Slough; 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. The role involves developing and executing the Global CSV Audit Strategy, collaborating closely with the CSV Audit Lead and Head of Global Quality Management. Ideal candidates will have a degree in natural science and extensive experience in quality assurance across relevant industries.

Benefits

Excellent salary and benefits

Bonus

Hybrid working arrangements

Qualifications

• Several years of experience in the IT, pharmaceutical, or medical devices industry.
• Experience with Regulatory Authorities, Quality Assurance for Manufacturing, and Clinical Development.

Responsibilities

• Develop and execute the Global CSV Audit Strategy and Plan.
• Support the development and documentation of the company’s Quality System.
• Manage global, regional, and local SOPs and WPs.

Skills

Quality Assurance

Computerised System Validation

Data Integrity

Education

Degree in natural science or equivalent business experience

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 arrangements.

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

1. Support the development, implementation, continuous improvement, and documentation of the company’s Quality System.
2. Support inspections.
3. Support the audit process.
4. Support the management of the global, regional, and local Standard Operating Procedures (SOPs) and Working Practices (WPs).
5. Support the validated state of computerised systems.
6. Provide advice and act as project liaison.

Skills

• Degree in natural science or equivalent business experience.
• Several years of experience in the Information Technology (IT) industry, pharmaceutical industry, medical devices industry, or with Regulatory Authorities, preferably including Quality Assurance for Manufacturing, Pharmacovigilance, Clinical Development, and Computerised System Validation and Data Integrity.