Overview

The Auditor, Clinical Quality and Compliance performs audits according to the audit plans, assessing and securing compliance in study conduct.

Overview (French)

Le rôle de l’auditeur, Qualité clinique et conformité est de réaliser des audits conformément aux plans d’audit, afin d’évaluer et d’assurer la conformité dans la conduite des études.

Requirements

Education

• Bachelor degree in a relevant discipline or equivalent experience

Experience

• Minimum of 3 years’ experience in the pharmaceutical or research industry (more specifically in clinical quality)

Knowledge And Skills

• Excellent knowledge of ICH guidelines, FDA and Health Canada regulations. Good knowledge of EU standards.
• Master the overall audit process including a systems-oriented approach, investigation/root cause determination and CAPA process.
• Ability to communicate effectively both orally ...