Eumedica

Eumedica est un laboratoire pharmaceutique indépendant spécialisé dans la production et la distribution de produits hospitaliers de niche. Notre vocation est d'assurer aux patients atteints de pathologies graves, voire rares, la continuité de leur traitement thérapeutique. C’est pourquoi nous avons fait de Ensuring Medical Care Continuity notre devise.

Nos principaux axes de développement sont:

    - l’extension de notre gamme de produits leaders dans le marché hospitalier
    - la spécialisation de nos services logistiques dans le stockage et la distribution de lots d’essais cliniques
      - la recherche sur la résistance bactérienne afin d’améliorer les traitements antibiotiques

A marché de niche, savoir-faire unique

Eumedica apporte également des réponses aux préoccupations logistiques d’autres sociétés pharmaceutiques, dont plusieurs multinationales qui font appel à nos services pour leur marché paneuropéen. Forts de notre expertise et de notre réseau de distribution en pleine expansion, nous garantissons à chacun de nos clients les meilleures compétences technologiques, opérationnelles et humaines.

Head of Quality Unit

EUMEDICA SA is an international reference actor in the pharmaceutical sector. We offer to pharmaceutical companies a wide range of custom-made services in various domains such as regulatory affairs, distribution and promotion of pharmaceutical products as well as tailored logistics services.
Based in Manage, we are looking for talented and dynamic profiles to complete our teams and accompany us in our development.

 

Head of Quality Unit

Description of the function:

In this role of Head of Quality Unit, you will make sure we are adhering strictly to the Guidelines on Good Distribution Practice and Good Manufacturing Practice of Medicinal Products.
You will manage the quality functions of Eumedica SA:
• Quality Control
• Quality Assurance
• Quality System
• Qualified Person


Your main responsibilities:

• Manage the Quality Unit teams
  o Define Objectives for the QU team and for each member of the team
  o Optimize Organizational Structure to meet QU objectives and keep compliance with GDP and GMP
  o Evaluate Performance of the QU team and of each member of the team (KPIs, …)
  o Develop QU Team and drive motivation
  o Ensure robust and collaborative relationships with Logistic Department/Operations

• Manage and Optimize the Quality Management System, mainly
  o Documentation Management System
  o Training System
  o Change Management
  o Deviations and CAPAs
  o Quality Complaints
  o Suppliers and Vendors Qualification
  o Qualification and Validation
  o Risk Quality Management
  o External and Internal audits

• Manage and Oversight the Quality Control operations
  o Quality Control of Incoming Goods
  o Quality Control of GMP operations
  o Ensure efficiency of Quality Control to operational and release planning

• Quality Assurance Management
  o Ensure the execution of the Quality Management Review process
  o Follow-up of Key Indicators Performance of the Quality Management System
  o Based on analysis of KPIs, results of audits, feedbacks from clients, identify actions to optimize the efficiency and quality of the Quality Mgt System
  o Review and Approval of Quality Agreement with suppliers and customers

• Manage the Quality Department Budget:
  o OPEX
  o CAPEX

• Represent the Quality Unit Department of Eumedica SA internally and externally.
  o Build good relationships and propose constructive solutions to internal colleagues and/or external clients

• Projects Involvement
  o New Product introduction
  o Quality Improvement Projects
  o Site Projects (e.g.: ERP)

 

As Head of Quality Unit you report directly to the Managing Director.


Your profile:

You have a Scientific Bachelor.
An experience of 10-15 years in the pharmaceutical manufacturing and/or distribution sector of pharmaceutical products in Quality department management positions.
An experience in Operations is an asset.
Proven people management skills.
Experience in Small and Medium size companies (CMO is a plus).
Your organization skills, your flexibility and your drive allow you to lead and achieve several projects at the same time. You have high analytical capabilities, which allow you to solve customer oriented problems and to contribute to the continuous improvements of our processes. You are stress resistant proactive, pragmatic and risk based approach oriented.
In addition, you have a very good knowledge of IT tools and are fluent in English and French (Dutch is a plus).


We offer:

• A full time job with a long term contract
• A salary package matching your competence,
• A dynamic and ambitious environment with possibility to develop your skills.

 

Working place:

Operational site in Manage (near Nivelles, easy to reach by car).


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