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Open nowPosted 5 days ago

QP Delegate

Start People

Where
Turnhout, Belgium
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Your applicationOpen nowQP DelegateStart People · Turnhout, Belgium

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  6. 58.7%60 days
This job: posted 5 days ago

The posting

Sanofi heeft meer dan 110.000 medewerkers, is gevestigd in meer dan 100 landen en is daarmee één van de grootste farmaceutische ondernemingen ter wereld. Sanofi’s sterktes zijn diabetesoplossingen, vaccins, innovatieve geneesmiddelen, consumer health care, opkomende markten en diergeneesmiddelen.

Door de overname van Genzyme in 2011 heeft Sanofi haar expertise op vlak van de biotechnologie en de behandeling van zeldzame ziektes versterkt . Vandaag geniet Sanofi Genzyme van het bereik en de middelen van een van 's werelds grootste farmaceutische bedrijven, met een gemeenschappelijk engagement om het leven van patiënten te verbeteren. De productiesite in Geel is een onderdeel van Sanofi’s Industrial Operations network en is het Center of Excellence voor de productie van therapeutische enzymen voor de behandeling van de ziekte van Pompe’s.

De productie van deze enzymen gebeurt via celculturen in grote bioreactoren, gevolgd door de opzuivering ervan. Op de site in Geel zetten zo’n 650 enthousiaste medewerkers zich elke dag ten volle in om dit complexe proces in goede banen te leiden.

Jobomschrijving

The QP Delegate serves as a key quality assurance representative, supporting the Qualified Person (QP) in ensuring compliance with regulatory requirements and internal quality standards for the release of commercial and clinical batches. While the QP delegate has the responsibility for approving the batch release dossier based on a detailed review of the batch release dossier content, the QP delegate relies on the pharmaceutical quality system of the site under the responsibility of the Qualified Person.

Key Responsibilities:

Quality & Batch Release

QP Governance & Escalation

Deviations & Change Control

Analytical & Product Specifications

Product Review

Shipment & Export

Reference Samples

  • Education: Master of Industrial Pharmacy
  • Certification: Valid QP number - recognized by the Belgian Minister of Health as Qualified Person as published in the Belgian official journal. QP initial training must be completed and kept up to date as described in QU-SOP-0037724.
  • Experience: Minimum 8–10 years in the pharmaceutical industry; prior experience as a QP is strongly preferred; extensive knowledge of and experience in biotechnology production processes
  • Languages: Fluency in both Dutch and English is required

Posting text belongs to the employer. Removal requests: contact us.

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