Deputy Responsible Pharmacist and Quality Assurance Manager

Reporting to the Head of Quality & Regulatory Affairs France / BeNeLux – Pharmacien Responsable, the

Regulatory Affairs & Quality Assurance - PRI support the Exploitant for :

> Exploitant Quality Assurance

› Taking part into the 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,

› Participating to training program of the affiliate‘s personnel,

› Contributing to continuous improvement of the Exploitant through risk analysis,

› Managing deviations/CAPAs/Change control,

› Managing Product Technical Complaints (PTC)

› Participating to Self-inspections/internal and external audits,

› Managing suppliers qualification/monitoring,

› Assisting the PR for products recall, and the potential cases of counterfeited products,

› Approve any returns to saleable stock if need be,

› Participate to inspection readiness,Taking part into Management Review and Quality Risk Management

› Reviewing the Product Quality Review

> Regulatory affairs

› Managing the MA lifecycle of the marketed products

› Reviewing packaging material of the product intended to be market on the territory,

› Performing Regulatory Intelligence,

› Assisting the PR in the management of out of stock situation,

› Set up MITM analysis and PGP, if ap