Eumedica

Eumedica is een onafhankelijk farmaceutisch bedrijf, gespecialiseerd in de productie en de distributie van ziekenhuisproducten. Onze taak bestaat erin om patiënten die lijden aan ernstige of zeldzame pathologische aandoeningen de continuïteit van hun therapeutische behandeling te garanderen. Vandaar ons motto: Ensuring Medical Care Continuity.

De voornaamste krachtlijnen van onze ontwikkeling zijn:

  • Uitbreiding van ons gamma toonaangevende producten in het ziekenhuismilieu;
  • Specialisatie van onze logistieke diensten in opslag en distributie van geneesmiddelen voor klinische studies;
  • Onderzoek van bacteriële resistentie teneinde antibioticabehandelingen te verbeteren.

Onze troef is onze unieke knowhow

Eumedica biedt ook antwoorden op de logistieke behoeften van andere farmaceutische bedrijven, waaronder meerdere multinationals, die voor hun pan-Europese markt een beroep doen op onze diensten. Dankzij onze expertise en ons distributienetwerk in volle expansie, kunnen wij aan al onze klanten de beste technologische en operationele ondersteuning bieden.

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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