stage cm quality system

il y a 6 jours


Paris, Île-de-France Ipsen Temps plein

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

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