Description du poste
POSITION
Job Title: Clinical and Medical Quality System Trainee
Division / Function: Clinical & Medical QA – Global Quality
Location: Paris, France
WHAT
- Summary & Purpose Of The Position
Ensuring a compliant state of the Quality Management System applicable to clinical studies managed by IPSEN R&D
and Medical Affairs (compliance to GCP, GVP, GPP, applicable regulation and standards).
Quality Systems
WHAT
- Main Responsibilities & Technical Competencies
Contribute to the maintenance of the Quality Management System governing clinical studies.Monitor quality performance of C&M QA: data collection, targets definition, best practices promotion,
improvement initiatives, and appropriate reporting.
Ensure proper management of eQMS records (Quality Events, system/process audits, Inspection readiness
and inspections, Change Control, process risk)
Training
Guide system users to ensure they are trained when required (e.g.
when a specific training task is required)Liaise with process owners and trainers to ensure appropriate training material is generated and made
available for clinical research activities
Quality Objectives and culture
Conduct periodic reviews of the quality system in scopeMonitor QMS KPIsProvide periodic quality updates to the Lead CM Quality SystemEncourage best practices, especially from a continuous improvement perspective.
Other
Respect and enforce current EHS regulations and procedures.Promote an EHS dynamic within the teams for the proper functioning of the EHS management systemEnsure that mandatory EHS training is carried out by its employee
HOW
- Knowledge & Experience
Education / Certifications (essential):
Bachelor’s degree or higher in relevant scientific life science or other relevant scientific qualifications
Education / Certifications (preferred)
Not Applicable
Language(s) (essential)
Fluent English and French
