QP Delegate
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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
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QP Delegate
Il y a 2 jours
Geel, Antwerpen, Belgique Sanofi Temps plein 80 000 € - 110 000 € ContratQP DelegateLocatie: GeelLevel: L2-2Hiring manager: Gunter AertsAbout the RoleThe 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...
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QP Delegate
Il y a 3 jours
Geel, Antwerpen, Belgique START PEOPLE Temps plein 80 000 € - 110 000 € ContratThe 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...
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QP Delegate
Il y a 4 jours
Geel, Antwerpen, Belgique Sanofi Group Temps plein 120 000 € - 150 000 € ContratAbout the RoleQP Delegate Locatie: Geel Level: L2-2 Hiring manager: Gunter AertsKey ResponsibilitiesQuality & Batch ReleaseActs as the first QP contact point for quality-related issuesPerforms detailed review and approval of batch release dossiersReviews and approves Certificates of Analysis / Certificates of ConformityChanges the Usage Decision in the ERP...
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QP Delegate: Batch Release
Il y a 2 jours
Geel, Antwerpen, Belgique Sanofi Temps plein 80 000 € - 110 000 € ContratSanofi Geel seeks a QP Delegate to support the Qualified Person in batch release for clinical and commercial products. You will review dossiers, approve COA/CoC, and ensure compliance within the site quality system.Requirements include a Master of Industrial Pharmacy, a valid QP number, 8–10 years in pharma, and fluency in Dutch and English. Based in Geel,...
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Senior QP Delegate
Il y a 4 jours
Geel, Antwerpen, Belgique Sanofi Group Temps plein 120 000 € - 150 000 € ContratSanofi Geel is seeking a QP Delegate (Location: Geel) to oversee quality and batch release activities. You will act as the primary QP contact for quality issues, review and approve batch release dossiers, and manage certificates of analysis/conformity.Key responsibilities include QP governance, deviations/change controls with regulatory impact, and approvals...
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Senior QP Delegate: Quality
Il y a 3 jours
Geel, Antwerpen, Belgique Jobat Temps plein 70 000 € - 90 000 € ContratSanofi Genzyme Geel seeks a QP Delegate to support the Qualified Person in ensuring regulatory and quality standards for the release of commercial and clinical batches. The role relies on the site pharmaceutical quality system and involves detailed review of batch release dossiers.You will collaborate with QA, manufacturing and governance to maintain...
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Quality Assurance Delegate for Batch Release
Il y a 3 jours
Geel, Antwerpen, Belgique START PEOPLE Temps plein 80 000 € - 110 000 € ContratSTART PEOPLE is seeking a QP Delegate to support the Qualified Person in ensuring regulatory compliance and quality standards for batch releases of commercial and clinical products. The role relies on the site’s pharmaceutical quality system and involves detailed review of batch release dossiers.The QP delegate approves batch release dossiers, oversees...
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Quality Assurance Associate – Delegate Qualified Person
Il y a 5 jours
Geel, Antwerpen, Belgique 7555-Janssen Pharmaceutica NV Legal Entity Temps plein 60 000 € - 96 000 € ContratAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...
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QP Delegate
Il y a 3 heures
Geel, Flanders, Belgique Start People Inhouse SANOFI Temps pleinDescriptionInterested in this role You can find all the relevant information in the description below.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...
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QP Delegate
Il y a 8 heures
Geel, Flanders, Belgique Sanofi Temps pleinh3QP Delegate /h3pLocatie: Geel /ppLevel: L2-2 /ppHiring manager: Gunter Aerts /ph3About the Role /h3pThe 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...