QA Project Manager

il y a 1 mois


Gent, Belgique MindCapture Temps plein

QA PROJECT MANAGER
- Biomedical engineering- Ghent & remoteWHAT IS OFFERED

MindCapture creëert een dynamische en stimulerende werkomgeving met een focus op de kandidaat. Wij geloven in duurzame relaties gebaseerd op hoogwaardige contacten en inzicht in carrièremogelijkheden, niet alleen voor onze kandidaten maar ook voor onze consultants, recruiters en ondersteunend personeel.

We belonen je met competitieve lonen en bieden je een sterk pakket met extra legale voordelen zoals maaltijdcheques, ecocheques, hoge ziektekostenverzekering (DKV) en groepsverzekering. Afhankelijk van uw anciënniteit kan een wagen ter beschikking worden gesteld.

Bovendien bieden wij persoonlijke training om jou te helpen groeien op het gebied van:

- Wat je graag wil doen
- Waar je goed in bent
- Waar en hoe je een impact wil hebben

ABOUT THE COMPANY

MindCapture is een talent matching bedrijf dat gespecialiseerd is in medical devices, pharma, en biotech. Als consultant krijg je de kans om diverse omgevingen te leren kennen en te ervaren. Bovendien bieden we zowel persoonlijke als professionele ondersteuning, vanuit MindCapture en onze partner. Voor dit project werken we samen met een internationaal medisch technologiebedrijf dat zich inzet voor het verbeteren van de gezondheidszorg door middel van innovatieve oplossingen.

Als QA Project Manager speel je een cruciale rol in het waarborgen van de kwaliteitsborging van de projecten. Je leidt het team en zorgt ervoor dat alle processen voldoen aan de geldende regelgeving.
- Toezicht op naleving van GMP/ATMP-normen tijdens de productie.
- Ontwikkelen en implementeren van QA-strategieën en samenwerking met R&D, productie en regulatory affairs.
- Uitvoeren van risicobeoordelingen en het ontwikkelen van risicobeperkende strategieën.
- Beoordelen en goedkeuren van SOP’s, batchrecords en validatierapporten.
- Onderzoeken van afwijkingen en implementeren van corrigerende en preventieve acties.
- Evalueren en implementeren van proces-, apparatuur
- en materiaalwijzigingen.
- Voorbereiden op interne en externe audits, en opvolging van bevindingen.
- Werken met interne teams en externe partners om kwaliteitsdoelen te behalen.

REQUIRED COMPETENCES & SKILLS
- Bachelor of Master in Farmacie, Engineering, Biotechnologie of een verwant vakgebied.
- Minimaal 5 jaar in kwaliteitsborging of projectengineering in de farmaceutische of biotechnologische sector.
- Leiden van kwaliteitsborging voor projecten, zorgen voor naleving van regelgeving. Ontwikkelen en implementeren van QA-strategieën en samenwerken met R&D, productie en regulatory affairs.
- Grondige kennis van FDA, EMA, GMP/ATMP en ICH-richtlijnen.
- Vaardigheid in kwaliteitsmanagementsystemen (QMS), procesvalidatie en risicobeheer.
- Sterke projectmanagement-, communicatie
- en probleemoplossende vaardigheden. Effectief in cross-functionele teams.
- Six Sigma of vergelijkbare certificeringen zijn een plus.



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