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 applicable

› Monitor shortage situation.

> Pharmaceuticals responsibilities

› 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

Requirements

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

Benefits

• Private Health Insurance
• Pension Plan
• Paid Time Off (25 + 11 days)
• Work From Home
• Training & Development
• Performance Bonus
• Meal Vouchers