Quality Assurance and Regulatory Affairs France - Lyon, France - Valneva

Valneva
Valneva
Entreprise vérifiée
Lyon, France

il y a 2 semaines

Sophie Dupont

Posté par:

Sophie Dupont

beBee Recruiter
Description
The Pharmaceuticals Affairs intern supports pharmaceuticals affairs activities of Valneva France SAS as defined in article

R :
Quality assurance, Wholesaling, Advertising, Regulatory Affairs. All activities are performed under the
Pharmacien Responsable supervision.


Responsibilities:

> Exploitant/Distributor Quality Assurance
› Support implementation, maintenance and improvement of the Quality Management System (QMS) of VALNEVA
France SAS in line with the Group Quality Policies, GMP/GDP&GVP guidelines and Public Health Code
› Contributing to continuous improvement of the Exploitant through risk analysis
› Support management of deviations/CAPAs/Change control management
› Support management of Product Technical Complaints (PTC) management
› Participate to Self-inspection/audit if need be
› Support suppliers qualification/management

> Regulatory affairs
› Recording MA modification of the marketed products in dedicated tracking table
› Reviewing packaging material of the product intended to be market on the territory,
› Assisting the department in the management of out of stock situation (review of PGP, )

> Advertising
› Support the department in the control of promotional activities.


Requirements:


Education /Experience:

  • 5th or 6th year student in pharmacy
  • Ideally a master degree in regulatory/quality affairs planned or ongoing

Required Skills:


  • Fluent in English, both written and spoken,
  • Ideally knowledge of GxP and Exploitant regulation
  • Sense of responsibility,
  • Good organizational skills,
  • Understanding of potential public health issues related to activity,
  • Ability to demonstrate ethics and confidentiality
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