Open role
Quality Officer - Audit & Self Inspection
- Aggregated by CV-Library
- Bedford, Bedfordshire
- Permanent
- Full Time
Job Description
Quality Audit Officer - Bedford
Are you a detail‑driven quality professional with a passion for compliance and client engagement? One of our leading pharmaceutical partners is seeking a Quality Audit Officer to join the Bedford team, where you'll play a pivotal role in hosting client audits and driving the self‑inspection programme across the business. This client‑facing role places you at the forefront of audit activities, ensuring compliance with ISO 9001, ISO 13485, and GDP regulations while building strong relationships with client quality teams.
Working alongside the Quality Integration Manager, you'll arrange and host audits, draft and submit audit responses, and act as the main point of contact for client queries. You'll also support regulatory inspections, lead self‑inspections, and contribute to continuous improvement initiatives that strengthen the company's Quality Management System.
Key Responsibilities
Arrange, host, and respond to client audits at Bedford and other UK sites as required
Act as subject matter expert or provide backroom support during regulatory inspections
Organise, perform, and report on self‑inspections across the UK
Oversee supplier qualification and maintain the Approved Supplier List
Conduct detailed root cause analysis of non‑conformances/deviations and implement corrective actions
Perform and facilitate risk assessments on GxP and quality processes
Identify training needs and update quality training materials based on audit findings
Review and improve SOPs, work instructions, and forms to ensure compliance and consistency
Build strong client relationships and communicate clearly with external quality teams
What We're Looking For
Minimum 3 years' experience in a quality department certified to ISO 9001 or ISO 13485
Strong working knowledge of GDP guidelines and Quality Management Systems
Experience in quality auditing and supplier qualification programmes
Skilled in Microsoft Office packages (Excel, Word, Visio, PowerPoint, Outlook)
Ability to work independently and in a team, under pressure and to strict deadlines
Confident communicator with excellent organisational and problem‑solving skills
Desirable:
QMS Lead Auditor qualification
Certified training within GxP
Are you a detail‑driven quality professional with a passion for compliance and client engagement? One of our leading pharmaceutical partners is seeking a Quality Audit Officer to join the Bedford team, where you'll play a pivotal role in hosting client audits and driving the self‑inspection programme across the business. This client‑facing role places you at the forefront of audit activities, ensuring compliance with ISO 9001, ISO 13485, and GDP regulations while building strong relationships with client quality teams.
Working alongside the Quality Integration Manager, you'll arrange and host audits, draft and submit audit responses, and act as the main point of contact for client queries. You'll also support regulatory inspections, lead self‑inspections, and contribute to continuous improvement initiatives that strengthen the company's Quality Management System.
Key Responsibilities
Arrange, host, and respond to client audits at Bedford and other UK sites as required
Act as subject matter expert or provide backroom support during regulatory inspections
Organise, perform, and report on self‑inspections across the UK
Oversee supplier qualification and maintain the Approved Supplier List
Conduct detailed root cause analysis of non‑conformances/deviations and implement corrective actions
Perform and facilitate risk assessments on GxP and quality processes
Identify training needs and update quality training materials based on audit findings
Review and improve SOPs, work instructions, and forms to ensure compliance and consistency
Build strong client relationships and communicate clearly with external quality teams
What We're Looking For
Minimum 3 years' experience in a quality department certified to ISO 9001 or ISO 13485
Strong working knowledge of GDP guidelines and Quality Management Systems
Experience in quality auditing and supplier qualification programmes
Skilled in Microsoft Office packages (Excel, Word, Visio, PowerPoint, Outlook)
Ability to work independently and in a team, under pressure and to strict deadlines
Confident communicator with excellent organisational and problem‑solving skills
Desirable:
QMS Lead Auditor qualification
Certified training within GxP