Smart4 Sciences
Quality Auditor
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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, 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.
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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 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
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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 GMP
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