QA Auditor - CSV

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

Benefits offered by this job

Hybrid work model

Job summary

Talentmark is partnering with an innovative UK biotechnology company to recruit a QA Auditor with CSV expertise to join its growing Quality team. The role can be at QA Auditor or Senior QA Auditor level, depending on experience.

Join a leading UK biotechnology organisation in London, offering hybrid working (2/3 on-site) and a competitive package. You'll maintain and enhance the Quality Management System, ensure GxP compliance, support regulatory inspections and QA projects.

Qualifications

• 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.
• 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 auditing

GCP auditing

CSV auditing

Quality Assurance

Education

Degree in a scientific field

Job description

QA Auditor / Senior QA Auditor - CSV

Hybrid | London | Permanent

Talentmark is partnering with an innovative UK biotechnology company to recruit a 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.

Join a leading UK biotechnology organisation making a real impact.

Hybrid working (2/3 days on-site).

Competitive salary and benefits package.

It is essential that applicants hold entitlement to work in the UK.