Senior Quality Assurance Auditor, CSV

Talentmark; Greater London; Hybrid; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid work model

Competitive benefits

Job summary

Talentmark is partnering with a UK biotechnology company to recruit a Senior QA Auditor with CSV expertise. The role is hybrid in London, permanent, with flexibility for QA Auditor or Senior QA Auditor level depending on experience.

The successful candidate will maintain and enhance the Quality Management System, ensure GxP compliance, and support regulatory inspections, with a focus on CSV auditing and GCP activities within a clinical site context.

Qualifications

• Experience in Quality Assurance within the pharmaceutical, biotechnology or life sciences sector.
• Internal auditing experience is essential.
• Strong experience auditing GCP clinical sites and CSV (Computer System Validation).
• Experience supporting regulatory inspections and external audits.
• Good understanding of GxP regulations and quality systems.

Responsibilities

• Planning and conducting internal audits across GCP and/or CSV activities.
• Performing supplier and vendor audits where required.
• Identifying compliance gaps and driving CAPA activities.
• Supporting regulatory inspections and client audits.
• Contributing to QA projects, quality systems and regulatory compliance initiatives.
• Promoting quality culture and continuous improvement throughout the organisation.

Skills

Internal audits

GCP auditing

CSV

GxP compliance

QA

Education

Degree in a scientific or related discipline

Job description

Senior QA Auditor / Senior QA Auditor – CSV

Hybrid | London | Permanent

Talentmark is partnering with an innovative UK biotechnology company to recruit a Senior QA Auditor with CSV expertise to join its growing Quality team. Our client is open to candidates at either QA Auditor or Senior QA Auditor level, depending on experience.

This is an excellent opportunity for an experienced Quality professional with Computer System Validation (CSV) auditing expertise and a GCP background in a clinical site auditing (esource, EQMS and LIMS systems).

The Role:

You'll play a key role in maintaining and enhancing the organisation's Quality Management System, ensuring compliance with GxP regulations and supporting continuous improvement across the business. You will be also supporting with regulatory training, eQMS and QA projects.

Responsibilities:

• Planning and conducting internal audits across GCP and/or CSV activities.
• Performing supplier and vendor audits where required.
• Identifying compliance gaps and driving CAPA activities.
• Supporting regulatory inspections and client audits.
• Contributing to QA projects, quality systems and regulatory compliance initiatives.
• Promoting quality culture and continuous improvement throughout the organisation.

Your Background:

• Degree in a scientific or related discipline preferred.
• Experience in Quality Assurance within the pharmaceutical, biotechnology or life sciences sector.
• Internal auditing experience is essential.
• Strong experience auditing GCP clinical sites and CSV (Computer System Validation).
• Experience supporting regulatory inspections and external audits.
• Good understanding of GxP regulations and quality systems.

Why Apply?

• Join a leading UK biotechnology organisation making a real impact.
• Hybrid working (2/3 days on-site).
• Competitive salary and benefits package.