Hays AG

Stellenangebot: Qualitätssicherung - Auditor (m/f/d)

Frankfurt Vollzeit

Jetzt bewerben

Über uns

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.

Aufgaben

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

Profil

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

Wir bieten

Working in an international environment

Gehaltsinformationen

This position is governed by the GVP collective agreement and is classified under pay grade 6. Your individual compensation will be determined based on factors such as your qualifications and professional experience