Quality Officer – Audit & Self Inspection

About the role

Smart4Sciences is seeking a detail‑driven Quality Officer to lead audit and self‑inspection activities for a leading pharmaceutical partner in Bedford. You will be the primary contact for client audits, ensuring compliance with ISO 9001, ISO 13485 and GDP regulations while supporting regulatory inspections.

Key responsibilities

• Arrange, host and respond to client audits at Bedford and other UK sites.
• Provide subject‑matter expertise and back‑room support during regulatory inspections.
• Organise, perform and report on self‑inspections across the UK.
• Maintain the Approved Supplier List and oversee supplier qualification.
• Conduct root‑cause analysis of non‑conformances and implement corrective actions.
• Perform 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 consistency.
• Build strong relationships with external client quality teams.

Required profile

• 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.
• Proficiency with Microsoft Office (Excel, Word, Visio, PowerPoint, Outlook).
• Ability to work independently and under pressure, meeting strict deadlines.
• Confident communicator with excellent organisational and problem‑solving skills.

Required skills

• ISO 9001
• ISO 13485
• GDP (Good Distribution Practice)
• GxP
• Microsoft Excel
• Microsoft Word
• Microsoft Visio
• Microsoft PowerPoint
• Microsoft Outlook