Head of Quality

NivellesIFarmaceutische industrie

Functieomschrijving

Description of the function:

In this role of Head of Quality, 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:

  • 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 the customer according to the current procedures
  • In charge of the approval of master labels
  • Ensure that the activities realized within customer enter within the scope of the current authorization of customer
  • Maintain the regulatory authorizations of the site updated according to the activities performed at the customer
  • Ensure a regulatory monitoring of GMP and GDP standards and regulations
  • Primary point of contact with Belgium authorities.
  • Manage the Product Quality Review's system
  • Perform the Product Quality Review Report writing and analyze/discuss trends.
  • Manage the recall procedure
  • Responsible to launch and manage product recall process
  • Approve the product’s returns
  • 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 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

 

Profiel

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 : 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.

You have a very good knowledge of IT tools.
You are fluent in English and French (Dutch is a plus).

Organisatie- en afdelingomschrijving

Select Projects is part of an international full-service Human Resources organization: Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium, the Netherlands and Dubai, we provide support to companies who need experienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

Aanbod

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop !

Heb je nog vragen?
Jerome Segers Business Unit Manager Wallonië Select Projects +32 473 20 73 32
Head of Quality Vacature informatie
62872
Gezondheidszorg, sociale- & medische diensten I Techniek, Productie, Constructie I Transport en logistiek I Management
Project sourcing
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