Quality Assurance Auditor (m/f/d)

Manage the full audit lifecycle, with a primary focus on Investigator Site AuditsAudit planning, scheduling and preparationScope and initial information reviewSite selection and project-team coordinationAudit execution / Audit reporting and follow-upCAPA and agreement review / Evidence review and audit closeout / Peer review of audit reportsConsultation with project teams regarding findings and CAPA responsesOccasional sponsor liaisonReview of internal procedures / Quality-improvement initiativesMaintenance of electronic quality-management and resource-tracking systemsOther 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 Hands-on, operational auditors, rather than primarily strategic or senior-management profilesExperienced in Investigator Site AuditsComfortable independently managing audits from planning through closeoutExperienced with practical audit activities including reporting, findings and CAPA follow-upAble to work autonomously and exercise sound judgment in both routine and unexpected audit situationsComfortable operating within a geographically distributed, remote European team Working in an international environment 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.

Responsibilities

Manage the full audit lifecycle, with a primary focus on Investigator Site AuditsAudit planning, scheduling and preparationScope and initial information reviewSite selection and project-team coordinationAudit execution / Audit reporting and follow-upCAPA and agreement review / Evidence review and audit closeout / Peer review of audit reportsConsultation with project teams regarding findings and CAPA responsesOccasional sponsor liaisonReview of internal procedures / Quality-improvement initiativesMaintenance of electronic quality-management and resource-tracking systemsOther 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

Benefits

Working in an international environment