Quality Assurance Auditor

An opportunity has arisen to join the Diomed Quality Assurance team as an External Auditor.

The auditor role will involve planning, conducting, documenting and concluding audits of Contract organisations and suppliers to Diomed. The role requires the successful applicant to consult with key stakeholders in Diomed to meticulously plan and carry out supplier audits across UK and overseas supplier sites before summarising, reporting and closing out of the audit. An excellent knowledge of regulatory requirements relating to GxP is required.

Your key responsibilities will be to:

• Conduct supplier audits of manufacturing facilities, laboratories, and quality systems to assess quality systems and ensure compliance with pharmaceutical standards including GMP (Good Manufacturing Practice), EMA, and other relevant regulatory requirements
• Review and evaluate Standard Operating Procedures (SOPs), batch records, validation protocols, and quality documentation
• Identify non-conformances, deviations, and areas for improvement; provide actionable recommendations
• Prepare detailed audit reports with findings, observations, and corrective action plans
• Track and verify implementation of Corrective and Preventive Actions (CAPA)
• Support regulatory inspections and external audits
• Stay current with evolving pharmaceutical regulations and industry best practices
• Collaborate with cross-functional teams including Production, Manufacturing, Engineering, Purchasing and Supply, and Regulatory Affairs
• Conduct risk assessments and participate in quality improvement initiatives
• Perform other routine tasks, as required.

What you’ll need to succeed:

• Exceptional written and verbal communication skills
• Strong attention to detail and ability to identify compliance gaps
• Excellent analytical and problem-solving skills
• Well organised and motivated individual
• Ability to plan and work well on own initiative
• Computer literate: able to use Microsoft Office, standard databases, and Quality Management Systems
• Certified Auditor
• Strong knowledge of GMP, FDA 21 CFR Parts 210/211, ICH guidelines, and other pharmaceutical regulations
• Previous experience in a similar role is essential