QA Releaser Biotech

il y a 6 jours


Gent, Belgique Science at Work Temps plein

Gent
- Bachelor, Master
- Uren per week: 40
- Erkenningsnummer: 2295\U
- Referentienummer: 84319

Voor een biotech bedrijf in Gent zoeken we een extra QA officer voor een vaste functie. Als QA-release officer waarborg je de kwaliteit van de gepersonaliseerde celtherapieproducten. Je werkt in een steriele, GMP-conforme omgeving om batchrecords te controleren, processen te verbeteren en klinische activiteiten te ondersteunen.

Taken:

- Het nakijken van de documentatie rond productie.
- Het controleren van papieren en elektronische batchrecords.
- Je onderzoekt non-conformiteiten.
- Je implementeert corrigerende maatregelen en werkt proactief om compliance problemen te verminderen.
- Je werkt volgens procedures onder GMP.
- Je werkt nauw samen met productieteams om afwijkingen in batchrecords op te lossen en de naleving ervan te garanderen.
- Je denkt na over mogelijkheden om batchrecordprocessen te verbeteren en doorlooptijden te verkorten om QA-deadlines te halen.

**Wie zoeken we?**:

- Je bezit een bachelor of master diploma biotech, biochemie, farma, MLT, FBT,..
- Je hebt reeds een paar jaar gewerkt binnen QA in een GMP-omgeving.
- Je kan je goed organiseren en nauwkeurig werken.
- Je hebt in een drukke omgeving een scherp oog voor detail en je blijft georganiseerd.
- Je bent een teamplayer.
- Je hebt sterke communicatieve vaardigheden.
- Als er snel beslissingen moeten worden genomen, blijf je kalm, je verwerk de informatie snel en je maakt weloverwogen keuzes.
- Je spreekt en schrijft vlot Nederlands en Engels.
- Je werkt in een vroege, dag en late shift en weekend (om de 2-3 weken) met de nodige flexibiliteit.
- Je hebt een goed begrip van cGMP-regelgeving, FDA/EU-richtlijnen.
- Je bent vertrouwd met technische rapporten en compliance-onderzoeken.

**Wat bieden we aan?**:

- Je komt in een innovatief biotech bedrijf terecht met veel potentieel.
- Je krijgt een contract onbepaalde duur met extralegale voordelen (groeps
- en hospitalisatieverzekering, maaltijdcheques, bonus, nettoonkosten vergoeding,..).
- Het bedrijf is bereikbaar met het openbaar vervoer.
- Voornaam
- Achternaam- Telefoonnummer
- Curriculum vitae
- Klik om een bestand te uploadenWe accepteren Word
- en PDF-bestanden tot 3 MB.
Ik ga akkoord dat Science at Work België (onderdeel van Pauwels Consulting Group) mijn gegevens verwerkt zoals voorgeschreven in de GDPR-wetgeving.- Kandidaten moeten wettelijk mogen werken in de EU en beschikken over de vereiste taalvaardigheden voor de werklocatie.**Verzenden


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