Eumedica is an independent pharmaceutical company specialising in the production and distribution of niche hospital products. We aim to ensure continuity of care for patients with serious, even rare diseases. This is why our motto is Ensuring Medical Care Continuity.

The focus for our development is the following:

  • expanding our range of product leaders in the hospital market
  • specialising our logistic services in the storage and distribution of clinical trial medicines
  • research in bacterial resistance to improve antibiotic treatment


Niche market, unique expertise

Eumedica provides solutions for the logistical needs of other pharmaceutical companies, including several multinationals who call on our services for their pan-European market. With our expertise and our rapidly growing distribution network, we guarantee each of our customers the best possible service, in terms of technology, operations and people.

 

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).

Your application will be evaluated by the HR department of Eumedica itself. For any additional feedback regarding your application, we kindly refer you to the Eumedica HR department.

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