Compliance and Quality officer
il y a 3 semaines
Op zoek naar een job binnen de farmaceutische sector? Ben je gebeten door kwaliteit? Kom je graag terecht bij een wereldspeler? En zijn glijdende uren een mooie extra voor jou? Lees dan zeker verder
Verantwoordelijkheden:- De vergunningen beheren (GMP-GDP-WDA): dit houdt in dat je de declaraties zal moeten monitoren, de informatie bij het FAGG (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten) en Notified Bodies zal moeten updaten.
- ISO 13485 en HACCP-autorisaties beheren.
- Leverancierskwalificaties en -evaluaties beheren, alsook het opstellen van auditplannen, de kwaliteitscontracten met externe partijen zoals CMO's, API-fabrikanten en leveranciers beheren. Bij dit takenpakket behoort ook het naleven van GMP-richtlijnen voor API-conformiteit en het aanvragen van vereiste verklaringen.
- Je zal de wijzigingen met registratie-impact moeten opvolgen en ondersteunen.
- Je zal het primaire aanspreekpunt zijn voor zowel lokale als bedrijfseigen kwaliteitsborging (QA) en regelgevende zaken (RA) bij het bedrijf zelf, evenals derden.
- Het opvolgen van veranderingen in wet- en regelgeving en het uitvoeren van bijbehorende GAP-analyses.
- De wijzigingen, Corrective and Preventive Actions (CAPA's) en behandeling van klachten beheren.
- De kwaliteitsborging in continuous improvement en technische overdrachtsprojecten vanuit een compliance-perspectief en in lijn met de RA-strategie ondersteunen.
- De risicobeoordeling met betrekking tot N-nitrosaminen opstellen, beoordelen en goedkeuren.
- De rapporten, procedures en documenten met betrekking tot het kwaliteitssysteem opstellen, beoordelen en goedkeuren.
- Je beschikt over een master in geneesmiddelenontwikkeling, bio-ingenieurswetenschappen, biomedische wetenschappen of vergelijkbare richting.
- Je kan terugblikken op een aantal jaar ervaring in een compliance rol, bij voorkeur binnen de farmaceutische sector. Bij voorkeur heb je ervaring opgedaan in kwaliteitsbeheer, zowel in de medische hulpmiddelen als de voedingssector.
- Je staat in nauw contact met alle afdelingen op de site en werkt intensief samen met je collega's.
- Je hebt uitstekende communicatieve vaardigheden om collega's te motiveren en enthousiast te maken.
- Als werker ben je een gestructureerde, planmatige, proactieve en resultaatgerichte persoon, die zowel zelfstandig als in teamverband uitstekend functioneert.
- Je kan werken met erkende MS Office-toepassingen (Word, Excel, PowerPoint), en kennis van SAP is een pluspunt. Kunnen werken met Trackwise is een troef.
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