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Open nowPosted 82 days ago

Quality Project Engineering

EURES job mobility portal314,718 open roles

Where
Antwerpen, Belgium
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Your applicationOpen nowQuality Project EngineeringEURES job mobility portal · Antwerpen, Belgium
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  5. 34.1%30 days
This job: posted 82 days ago

The posting

Functieomschrijving

Ben jij analytisch sterk, kwaliteitsgericht en gedreven om processen continu te verbeteren? Als Quality Engineer – Lab Operations speel je een sleutelrol in het waarborgen van de kwaliteit binnen onze laboratoriumactiviteiten. Je onderzoekt analytische afwijkingen, identificeert de grondoorzaken en ontwikkelt doeltreffende Corrective and Preventive Actions (CAPA's) om herhaling te voorkomen.

Je werkt nauw samen met verschillende afdelingen en fungeert als aanspreekpunt voor kwaliteitsgerelateerde vraagstukken. Dankzij jouw analytisch inzicht en gestructureerde aanpak draag je actief bij aan de continue verbetering van onze kwaliteitsprocessen.

Jouw verantwoordelijkheden

  • Uitvoeren van kwalitatief onderzoek naar analytische afwijkingen binnen Lab Operations.
  • Achterhalen van de grondoorzaken van afwijkende analyseresultaten.
  • Opstellen, implementeren en opvolgen van Corrective and Preventive Actions (CAPA's).
  • Uitvoeren van trendanalyses om terugkerende kwaliteitsproblemen te identificeren.
  • Definiëren en implementeren van structurele verbeteracties op basis van analysegegevens.
  • Rapporteren van de voortgang en effectiviteit van CAPA's aan het management.
  • Ontwikkelen en opvolgen van Key Performance Indicators (KPI's) om kwaliteitsafwijkingen te monitoren.
  • Correct en nauwkeurig documenteren van onderzoeksresultaten volgens de geldende kwaliteitsrichtlijnen.
  • Samenwerken met verschillende interne stakeholders om kwaliteitsprocessen continu te optimaliseren.

Jouw profiel

Must-have

  • Masterdiploma in Industrieel Ingenieurswetenschappen, Farmaceutische Wetenschappen, Bio-ingenieurswetenschappen of een gelijkwaardige opleiding.
  • Minstens 1 jaar ervaring binnen de farmaceutische industrie of gelijkwaardige ervaring in een relevante kwaliteitsfunctie.
  • Sterke analytische vaardigheden en ervaring met probleemoplossend onderzoek.
  • Een proactieve en continu verbetergerichte mindset.
  • Uitstekende communicatieve vaardigheden en het vermogen om relaties op te bouwen met interne en externe stakeholders.
  • Assertief, empathisch en diplomatisch in samenwerking met verschillende partijen.
  • Sterke schriftelijke vaardigheden voor heldere en correcte rapportering en documentatie.
  • Kwaliteitsbewust en nauwkeurig.
  • Goede kennis van analytische (bio)chemische technieken zoals:

(U)HPLC, GC, UV/VIS, Karl Fischer, AAS, Titratie, Blotting, SDS…

  • Zeer goede kennis van het Nederlands en Engels.

Nice to have

  • Ervaring met het behandelen van afwijkingen (Deviations) en CAPA-processen.
  • Ervaring binnen een cGMP-gereguleerde omgeving.
  • Ervaring met cross-functionele samenwerking.
  • Ervaring met het rapporteren van kwaliteitsindicatoren aan management.
  • Teamspeler met een open, constructieve en proactieve communicatiestijl.
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