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Open nowPosted 39 days ago

Senior QC Laborant - Methodeontwikkeling & Validatie

EURES job mobility portal314,718 open roles

Where
Gent, Belgium
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Your applicationOpen nowSenior QC Laborant - Methodeontwikkeling & ValidatieEURES job mobility portal · Gent, Belgium

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Share of postings closed within
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  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 39 days ago

The posting

Conforma NV, een farmaceutisch bedrijf in volle expansie, is op zoek naar een Laborant om ons team te versterken. Onze kernactiviteiten zijn de productie en verpakking van vloeistoffen en semi-vaste stoffen binnen de domeinen geneeskunde en cosmetica. We zijn gelegen in Destelbergen en zijn een internationale speler met een sterke focus op innovatie en kwaliteit.

Voor ons kwaliteitscontrolelaboratorium binnen de farmaceutische industrie zoeken we een ervaren Senior QC Laborant met expertise in analytische methodeontwikkeling en validatie.

Je combineert hands-on laboratoriumwerk met verantwoordelijkheid voor het ontwikkelen, optimaliseren en valideren van analytische methodes. Daarnaast neem je het analytische luik van de dossiers voor farmaceutische grondstoffen op en verzorg je de communicatie hierover met het FAGG.

Jouw verantwoordelijkheden:

  • Ontwikkelen, optimaliseren en implementeren van analytische methodes
  • Opstellen van validatieprotocollen en -rapporten volgens de geldende regelgeving en richtlijnen
  • Zelfstandig uitvoeren van methodevalidatie en interpreteren van de resultaten
  • Onderzoeken en oplossen van analytische problemen
  • Opstellen en onderhouden van het analytische dossier voor grondstoffen in het kader van het Grondstoffenbesluit
  • Evalueren van bestaande vergunde dossiers en bepalen welke updates nodig zijn om aan de geldende regelgeving te blijven voldoen
  • Voorbereiden van analytische informatie en opvolgen van vragen van het FAGG
  • Bachelor- of masterdiploma in chemie, farmaceutische wetenschappen, biochemie of een vergelijkbare richting
  • Meerdere jaren ervaring in een QC-laboratorium binnen de farmaceutische industrie
  • Aantoonbare ervaring met analytische methodeontwikkeling, optimalisatie en validatie
  • Ervaring met het opstellen van validatieprotocollen en -rapporten
  • Goede kennis van GMP en relevante richtlijnen voor analytische validatie
  • Sterk analytisch vermogen en ervaring met het kritisch beoordelen en interpreteren van resultaten
  • Ervaring met analytische dossiers voor grondstoffen en/of communicatie met het FAGG is een plus
  • Je werkt nauwkeurig, zelfstandig en gestructureerd
  • Goede communicatieve vaardigheden, een zeer goede kennis van het Nederlands en een goede kennis van het Engels
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