Quality Assurance and Regulatory Affairs France Internship
Valneva, France
Job Description
Valneva is a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to commercialize three vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against the chikungunya virus and Lyme disease.
The Pharmaceuticals Affairs intern supports pharmaceuticals affairs activities of Valneva France SAS as defined in article
R.5124-2-3: Quality assurance, Wholesaling, Advertising, Regulatory Affairs. All activities are performed under the
Pharmacien Responsable supervision.
Responsibilities:
gt; 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/GDPamp;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
gt; 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,)
gt; 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 on-going
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