Technical skills

SRE

About this role

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 applicable

› Monitor shortage situation.

› Assuming pharmaceutical responsibility in the planned/unplanned absence of the Pharmacien Responsable.
> General support
› Promoting Exploitant regulation approach with internal and external stakeholders and control its implementation,
› Developing trusting professional relationship with governmental authorities

✓ Graduated Pharmacist,
✓ At least 3 years of experience in a Pharmaceuticals Exploitant
✓ Experience compliant to article R.5124-16, R.5121-164 of French health code,
✓ Registered/registrable at the College of Pharmacists section B as Pharmacien Responsable Intérimaire Exploitant.
✓ Ideally a master degree in regulatory/quality affairs
✓ Fluent in English, both written and spoken,
✓ Solid knowledge of GxP and Exploitant regulation
✓ High sense of responsibility,
✓ Excellent management and organizational skills,
✓ Ability to make decisions including in stressful situation,
✓ Sense of priority and deadlines,
✓ Perfect understanding of potential public health issues related to activity,
✓ Ability to demonstrate independence, objectivity, ethics and confidentiality