Deputy Responsible Pharmacist and Quality Assurance Manager – Lyon, France

Il y a 2 jours

Lyon, Auvergne-Rhône-Alpes, France Valneva SE Temps plein

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

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

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.

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

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