Senior Qa Auditor - Csv

Ck Group; England; On-site; GBP 42,000 - 66,000; Full time

Job summary

Talentmark is assisting a leading UK biotechnology company to appoint a QA Auditor with CSV expertise. The role can be filled at QA Auditor or Senior QA Auditor level depending on experience.

The candidate will join a growing Quality team and contribute to maintaining the organisation's Quality Management System in line with GxP regulations. You will audit internal processes, perform CSV-related audits, support regulatory inspections, and contribute to CAPA and QA projects.

Qualifications

• Degree in a scientific or related discipline preferred.
• Experience in Quality Assurance within pharmaceutical, biotechnology or life sciences sectors.
• Internal auditing experience is essential.
• Strong experience auditing clinical sites and CSV (Computer System Validation).

Responsibilities

• Plan and conduct internal audits across GCP and/or CSV activities.
• Perform supplier and vendor audits as required.
• Identify compliance gaps and drive CAPA activities.
• Support regulatory inspections and client audits.
• Contribute to QA projects, quality systems and regulatory compliance initiatives.
• Promote quality culture and continuous improvement throughout the organisation.

Skills

QA Auditing

CSV Auditing

GxP Compliance

Internal Auditing

Regulatory Training

CAPA

QA Projects

Education

Degree in scientific discipline

Job description

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 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 clinical sites and CSV (Computer System Validation).