Deputy Responsible Pharmacist and Quality Assurance Manager

Valneva; Lyon; Hybride; EUR 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Private Health Insurance

Pension Plan

Paid Time Off (25 + 11 days)

Work From Home

Training & Development

Performance Bonus

Meal Vouchers

Résumé du poste

Valneva France SAS is seeking a Pharmacist to support Exploitant Quality Assurance and Regulatory Affairs, ensuring QMS conformance with GMP/GDP/GVP and public health codes.

The role covers deviations, CAPAs, supplier qualification, audits, recalls, and regulatory lifecycle management with a focus on quality risk management. French health code compliance and strong organizational skills are essential.

Qualifications

• Graduated Pharmacist with regulatory/quality focus.
• Experience compliant to French health code regulatory articles.
• Ability to manage deviations/CAPAs/Change control and PTC.

Responsabilités

• Implement, maintain and improve the QMS in line with Group Quality Policies and GMP/GDP/GVP.
• Participate in training, risk analysis and internal/external audits.
• Manage supplier qualification/monitoring and recalls/anti-counterfeit cases.

Connaissances

Regulatory affairs

Quality Assurance

GxP knowledge

Decision making under pressure

Organizational skills

Formation

Pharmacist degree

Master in regulatory/quality affairs

Description du poste

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

Qualifications

• 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

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