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QA Specialist B
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QA Specialist B
- Ermelo, Gelderland, Netherlands
- Ermelo, Gelderland, Netherlands
Über
Abbott Biologicals in Olst is wereldwijd verantwoordelijk voor het afvullen van lactulose, de productie van hormoonpreparaten en het formuleren van Mebeverine. Daarnaast worden op deze locatie het griepvaccin Influvac® afgevuld en diverse producten vervaardigd via contract manufacturing. Voor deze activiteiten geldt Olst als hét Center of Excellence binnen Abbott.
De afdeling Quality Assurance Supplier to Customer (QA StoC) speelt een cruciale rol binnen Abbott Biologicals Olst, en de zuster locatie in Weesp. QA StoC is medeverantwoordelijk voor het waarborgen van de kwaliteit en compliance van onze producten gedurende de hele keten — van leverancier tot klant. De afdeling houdt toezicht op leveranciers, beheert binnenkomende klachten, fungeert als Lokal Key User van het SAP systeem en draagt zorg voor Regulatory Compliance.
Voor de afdeling Quality Assurance Supplier to Customer zijn wij op zoek naar een Quality Assurance Specialist A met focus op Regulatory Compliance .
Wat ga je doen?
Als QA Specialist ben je verantwoordelijk voor het waarborgen van de kwaliteit van onze producten en het naleven van wet- en regelgeving. Je werkt in een team van QA Specialisten en Officers en rapporteert aan de QA StoC Manager. Je hebt intensief contact met collega’s binnen diverse afdelingen in Olst én met internationale teams.
Je taken omvatten onder andere:
- Toezien op de naleving van kwaliteitsrichtlijnen;
- Beoordelen van lokale wijzigingen op impact voor registratiedossiers;
- Evalueren van globale wijzigingen op lokale processen;
- Behandelen van verzoeken van autoriteiten (zoals renewals);
- Deelname aan en ondersteuning van projecten en initiatieven (zoals productlanceringen);
- Samen met multidisciplinaire teams verbeteracties definiëren en implementeren;
- Op termijn uitbreiding van je werkzaamheden richting andere QA StoC-disciplines.
Wat breng je mee?
- Een afgeronde BSc of MSc in bijvoorbeeld Biomedische Wetenschappen, Farmacie, Biochemie of Levensmiddelentechnologie;
- Aantoonbare affiniteit met Regulatory Compliance en QA-werkzaamheden;
- Een proactieve en assertieve werkhouding;
- Sterke vaardigheden in stakeholdermanagement;
- Uitstekende beheersing van zowel de Nederlandse als Engelse taal (professioneel niveau);
- Beschikbaarheid voor een fulltime functie op locatie (40 uur per week).
Competenties
Je herkent jezelf in de volgende eigenschappen:
- Nauwkeurig
- Gestructureerd
- Empathisch
- Samenwerkend
- Constructief
- Resultaatgericht
Waarom Abbott?
Bij Abbott werk je aan producten die wereldwijd het verschil maken in het leven van mensen. Je krijgt de kans om te groeien in een internationale en innovatieve omgeving, met aandacht voor persoonlijke ontwikkeling en samenwerking.
Sprachkenntnisse
- English
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