Manufacturing System Quality Partner
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- Support BPF / GMP sur le terrain : réalisation de compliance tours, spot-checks en zone GMP et accompagnement lors des inspections.
- Gestion du QMS & Déviations : analyse, investigation et résolution des écarts, déviations, OOS et suivi des CAPA.
- Change Control & Validation : évaluation QA des Change Controls et support qualité pour la qualification/validation des équipements et systèmes d'information (IT).
- Amélioration continue : approbation et revue des SOPs, protocoles, rapports et dossiers de transfert technique.
VOTRE PROFIL
- Solide compréhension des exigences réglementaires BPF / GMP appliquées au secteur de la biotechnologie / biopharma (Drug Substance, opérations de laboratoire, systèmes qualité).
- Expérience confirmée en Assurance Qualité (QA) opérationnelle et analyse des risques.
- Grande autonomie, proactivité et aisance dans la gestion de situations complexes.
- Excellent niveau d'Anglais (oral et écrit). POURQUOI CE POSTE ?
- Un rôle transversal à fort impact au contact des équipes de développement, de production et IT.
- Un environnement stimulant à la pointe de l'innovation biotechnologique. Envie de relever le défi ? Postulez directement en envoyant votre CV Hanna.mimouni@randstad.be #PharmaJobs #Biotech #QualityAssurance #GMP #JobsInBelgium #Recrutement #QA #BioPharma
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