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Quality Audit Officer – Bedford
One of our leading pharmaceutical partners is seeking a Quality Audit Officer to join the Bedford team. In this pivotal client-facing role, you will play an essential part in hosting client audits and driving the self-inspection programme across the business.
About the Role
Ensuring ISO 9001, ISO 13485, and GDP compliance while fostering strong relationships with client quality teams is crucial. Working closely with the Quality Integration Manager, you’ll coordinate audits, respond to client findings, and support regulatory inspections. Additionally, you’ll lead self-inspections and contribute to continuous Quality Management System (QMS) improvements.
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Key Responsibilities
- Arrange, host, and respond to client audits (Bedford and UK sites as needed)
- Provide subject matter expertise or 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 root cause analysis of non-conformances 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 for compliance
- Build strong client relationships and liaise effectively with external quality teams
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Requirements
Desirable Skills & Experience
- Minimum 3 years’ experience in a quality department certified to ISO 9001 or ISO 13485
- Strong knowledge of GDP guidelines and Quality Management Systems
- Compliance experience in quality auditing and supplier qualification
- Proficiency in Microsoft Office (Excel, Word, Visio, PowerPoint, Outlook)
- Ability to work independently and under pressure, with exceptional organisational skills
- Excellent communication and problem-solving capabilities
Desirable
- QMS Lead Auditor qualification
- Certified GMP training
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