Senior R&D QA GCP Auditor

Carrot Recruitment; Manchester; On-site; GBP 45,000 - 70,000; Full time

Job summary

A leading recruitment company is seeking a clinical auditor to support compliance and implementation of GCP and GCLP in clinical development projects. This role involves conducting thorough audits, managing audit findings, and ensuring adherence to clinical trial regulations. Candidates should possess extensive experience in GCP audits and strong leadership skills, alongside the flexibility to travel within the UK and Europe.

Qualifications

• Demonstrable experience in GCP ICH E6.
• Vast experience in completing GCP audits across multiple sites.
• Ability to travel within the UK and Europe.

Responsibilities

• Support the compliance and implementation of GCP and GCLP.
• Conduct mock inspections and audits internally and externally.
• Maintain the annual audit programme of auditing activities.

Skills

Leadership

Decision Making

Communication

Tools

Trackwise

Job description

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• Support the compliance and implementation of GCP and GCLP across the clinical development of global projects.
• Audit management from start to finish, from agenda to report
• Conduct mock inspections and audits internally and externally, virtually and onsite
• Support the department to analyse the finding of audits and manage accordingly
• Maintain the annual audit programme of auditing activities

You

• Demonstrable experience in GCP ICH E6 and knowledge of clinical development phases alongside the management of IMPs within clinical trials.
• Vast experience of completing GCP audits across multiple sites within the UK
• Familiar with Trackwise or similar electronic systems alongside frequently auding electronic medical records
• Superior management skills relating to leadership, organisation, decision making and communication.
• Ability to travel within the UK and Europe