Senior Quality Associate/quality Manager
il y a 4 semaines
place
- Ghent- , Belgiquework_history
Experience 2 à 5 ans
CDI
- dans le secteur Life Sciences**L'offre**:
Om tegemoet te komen aan onze groeiende groei, zijn we op zoek naar een QA/Quality Manager. Meer specifiek, een georganiseerde en resultaatgerichte teamspeler die alle details nauwlettend in de gaten houdt.
Verantwoordelijkheden:
- Vrijgeven van alle voorraadhoudende items (grondstoffen, verpakkingsmaterialen, eindproducten, marketingmaterialen)
- Verantwoordelijk voor het vrijgeven van alle voorraadhoudende items.
- Uitvoeren van kwartaalwijze batchrecordbeoordelingen.
- Leveranciers
- Dagelijks contact met serviceleveranciers die een directe impact kunnen hebben op de productkwaliteit en/of prestaties (productie, testen, regelgeving) (bijv. onderaannemer)
- Klanten
- Adres en controle van klantspecifieke kwaliteitseisen (goedkeuringen van productiedossiers)
- Documenteren en opvolgen van herstelverzoeken van klanten.
- Non-conformiteiten van product/materiaal/dienst
- Verantwoordelijk voor opvolging en onderzoek van non-conformiteiten. Dit omvat non-conforme producten die voor en na levering zijn gedetecteerd, Out-of-specifications (OOS) en afwijkingen. Dit is ook van toepassing op OOS/Afwijkingen gemeld door de leveranciers.
- Verantwoordelijk voor de evaluatie van de initiële informatie om te bepalen of het feedback vormt een klacht de registratie, het onderzoek, de daaropvolgende acties en de goedkeuring/definitieve afsluiting van de non-conformiteiten.
- Verantwoordelijk voor klachtenafhandeling, incl. communicatie met klanten en leveranciers.
- CAPA (Correctieve en preventieve maatregelen)
- Verantwoordelijk voor het initiëren, onderzoeken van CAPA en indien nodig uitvoeren van 'Productgerelateerde' corrigerende en/of preventieve maatregelen.
- Klachten
- Opstellen van kwartaalverslag klachten van klanten
- Bepaling van de basislijn en drempel voor de klachten voor alle legacy
**Profil recherché**:
**Skills**:
- Relevant masterdiploma
- Minstens een eerste relevante ervaring
- Kennis van zowel Nederlands als Engels
- Ervaring met vrijgaven en CAPA-afhandeling is een must
- Kennis van ISO13485 (of ervaring met vrijgaven van geneesmiddelen)
- Rijbewijs
Bij ons draait het niet om het invullen van vacatures; het gaat erom dat we talent aantrekken dat onze bedrijfscultuur verrijkt en onze ambities deelt. We zijn vastbesloten om een werkomgeving te creëren waarin onze medewerkers kunnen excelleren en hun professionele groei kunnen bevorderen.
Stel je voor: elke dag werkend in een omgeving waar transparantie, samenwerking en openheid de basis vormen. Een plek waar ideeën worden verwelkomd en waar er ruimte is voor innovatie en verbetering.
Bij ons draait het niet alleen om de uitdagingen die we aangaan, maar ook om de manier waarop we ze benaderen. Integriteit, eerlijkheid en respect zijn voor ons essentiële waarden die we koesteren in ons team.
En wat betreft de beloningen: naast een competitief salaris bieden we een uitgebreid pakket aan voordelen en ontwikkelingsmogelijkheden.
Dus, als je op zoek bent naar een professionele uitdaging waar je jezelf kunt ontplooien en een positieve impact kunt maken, nodigen we je uit om deel uit te maken van ons team van deskundigen. Samen streven we naar uitmuntendheid en succes.
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