About this role
Your Benefits
- Working in an international environment
Your Duties
- Manage the full audit lifecycle, with a primary focus on Investigator Site Audits
- Audit planning, scheduling and preparation
- Scope and initial information review
- Site selection and project-team coordination
- Audit execution / Audit reporting and follow-up
- CAPA and agreement review / Evidence review and audit closeout / Peer review of audit reports
- Consultation with project teams regarding findings and CAPA responses
- Occasional sponsor liaison
- Review of internal procedures / Quality-improvement initiatives
- Maintenance of electronic quality-management and resource-tracking systems
- Other GCP clinical project audits, such as TMF, Data Management and Clinical Study Report audits, may also form part of the role, although previous experience in these areas is not mandatory
Your Qualifications
- Hands-on, operational auditors, rather than primarily strategic or senior-management profiles
- Experienced in Investigator Site Audits
- Comfortable independently managing audits from planning through closeout
- Experienced with practical audit activities including reporting, findings and CAPA follow-up
- Able to work autonomously and exercise sound judgment in both routine and unexpected audit situations
- Comfortable operating within a geographically distributed, remote European team
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.