Auditeur, GCP
Responsabilités
The GCP Auditor is responsible for quality assurance auditing of all activities subject to the, « ICH Good Clinical Practice: Ligne directrice consolidée, » (GCP), soutenir un programme d’assurance qualité (Assurance qualité) to ensure that AGN project data and summary statements are of known and documented quality.
Summary of Responsibilities:
- Audit of Activities and Vendors Subject to GCP regulations
- With manager oversight, liaise with Business Customers and Compliance Partners to Support the Identification & Atténuation des risques au sein d’AGN R&D/MA (Appareils pharmaceutiques et médicaux)
- Interface avec la qualité & Fonctions de conformité
- Interface avec les agences de régulation
Exigences
Formation et expérience
- Baccalauréat requis
- Scientific training and advanced degree are desirable
- GCP knowledge gained through 1-5 years GCP audit experience
- Scientific background with demonstrated hands on knowledge of the clinical environment with specific experience in 1) un rôle de développement de médicaments ou un 2) rôle d'inspecteur d'un organisme de réglementation.
- Basic knowledge of worldwide regulatory requirements and/or pharmaceutical development practices.
- Connaissance/compréhension de l'approche et des perspectives des agences de réglementation.
Compétences et capacités essentielles
- Good written and verbal communication skills, demonstrated ability to function strategically and effectively with all levels of management
- Strong negotiation and relationship building skills
- Haut degré de conscience organisationnelle
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