uditore, GCP

responsabilità

The GCP Auditor is responsible for quality assurance auditing of all activities subject to the, “ICH Good Clinical Practice: Guideline consolidato,” (GCP), supporting a program of quality assurance (QA) 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 & Mitigation of Risk within AGN R&D/MA (Pharma and Med Devices)
  • Interface with Quality & Compliance Functions
  • Interface with Regulatory Agencies

Requisiti

Education and Experience

  • Bachelors degree required
  • 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) a drug development role or a 2) regulatory agency inspector role.
  • Conoscenza di base dei requisiti normativi in ​​tutto il mondo e / o pratiche di sviluppo farmaceutico.
  • Conoscenza / comprensione dell'approccio e prospettive di agenzie di regolamentazione.

Abilità e capacità essenziali

  • Buone capacità di comunicazione scritta e verbale, demonstrated ability to function strategically and effectively with all levels of management
  • Forte di negoziazione e di relazione costruzione di competenze
  • High degree of organizational awareness

 


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