Les offres d'emploi : Professions sociales - Santé ...

The successful candidate will be responsible for:

- preparation, conduction of Clinical Quality audits to assure compliance to our client's established standards and regulations (audits will be conducted also abroad and locally in CRO, Laboratories, Clinical Investigator Sites and pharmacovigilance systems)
- results report of Health Authority Inspections.
- improvement of quality process and assessment audits results to identify GxP training needs
- evaluate pertinence of CAPA
- up to date the GCP/PV regulations with local and international regulations
- establishment of partnership with all business unit and CAO, CRO, Clinical site to provide them information on risk assessment of GxP regulations, guidelines.
Professional experience and skills:

- at least 4 years in clinical/ biotech or pharma industry with experience in GCP/PV auditing
- knowledge of computer validation and Part 11 requirements

Personal skills:

- objectiv, rigorous, excellent interpersonal skills.

Education

- a minimum Bachelor of Science Degree in Pharmacy, Chemistry, Biology
- fluent in english and french.


Michael Page...