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.

Pharmacist – Qualified Person

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.

 Pharmacist – Qualified Person

 

Description of the function:

In this role of QP, you will make sure we are adhering strictly to the Guidelines on Good Distribution Practice and Good Manufacturing Practice of Medicinal Products. Also you will apply the requirements of the customers and the quality policy of the company regarding the operations of secondary packaging, release, storage and distribution of medicinal products.

 

Your main responsibilities:

Batch Review and Release

  • Manage the system of batch review and release
  • Release products according to the procedure (QP confirmation and certification)
  • Review and approve the deviation reports and incoming complaints
  • Verify the documents of conformity and the packaging of commercial products according to the procedure
  • Verify the additional labeling according to the procedures for clinical trial supply
  • Ensure the GMP certification of secondary packaging performed at Eumedica according to the current procedures
  • In charge of the approval of master labels

 

 GxP Authorization & Regulatory

  • Ensure that the activities realized within Eumedica enter within the scope of the current authorization 860 (H and IMP) of Eumedica
  • Maintain the regulatory authorizations of the site updated according to the activities performed at Eumedica
  • Ensure a regulatory monitoring of GMP and GDP standards and regulations
  • Primary point of contact with Belgium authorities.

  

Product Quality Review

  • Manage the Product Quality Review's system
  • Perform the Product Quality Review Report writing and analyze/discuss trends.

  

Recall and Return Processes

  • Manage the recall procedure
  • Responsible to launch and manage product recall process
  • Approve the product’s returns

  

External Quality

  • Manage the quality agreement procedure
  • Review and Approve the quality contracts with the customers and the suppliers (Quality Agreement)
  • Approve GxP suppliers

  

Others

  • Manage the counterfeiting process and procedure
  • Lead projects linked to Quality topics
  • Member of the CC board to assess change request
  • Involve in several processes/projects where the QP insight is required
  • Participate to Quality Meetings (internal and external)
  • Involve in Quality Management Review Process
  • Participate to Customers audit when needed

 

 As Qualified Person you report directly to the Head of Quality Unit.

  

Your profile:

You have a Master degree in Industrial Pharmacy and you have been certified by FAMHP as a Qualified Person. An experience of 5-10 years in the pharmaceutical manufacturing and/or distribution sector of pharmaceutical products should be an asset. 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).

Twoje podanie bedzie oceniane przez sam dzial HR Eumedica . W celu uzyskania dodatkowych informacji dotyczacych aplikacji, przekierujemy cie do dzialu HR Eumedica.


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