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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 scope
- Monitor QMS KPIs
- Provide periodic quality updates to the Lead CM Quality System
- Encourage 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 system
- Ensure 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
