Quality Systems Technician
Il y a 5 mois
Pour le département Assurance Qualité, PolyPeptide SA est à la recherche d'un(e) Quality Systems Technician .
Support technique aux services QA de Polypeptide SA ainsi qu’à l’ensemble du site pour les activités AX/LIMS Labware (codification, release,…), l’archivage, le support QUMAS (Document et Compliance),…
Les principales responsabilités de la fonction sont :
- Gestion de la qualification des fournisseurs de matières premières et laboratoires de service analytique (gestion des audits, des formulaires, des assessments,…)
- Gestion de la partie QA d’AX et LIMS Labware pour : la codification des items, le release des matières premières, la gestion des master data, approbation des nouvelles spécifications,…
- Gestion des archives GMP : gestion en interne et transfert chez le sous-traitant.
- Revue et approbation de change Control, déviation, CAPA liés aux matières premières.
- Administrateur QUMAS pour les systèmes Doc-Compliance et Process-Compliance (change control, déviation et CAPA).
- Revue/rédaction des TQSBR spécifiques aux matières premières (ex : ACN,..).
- Revue et approbation de SOP
- Gestion et suivi de l’adhérence du planning des audits internes.
- Suivi et analyse des KPI’s afin de préparer les présentations du Quality council.
- Support dans la rédaction des réponses aux rapports d’audits clients.
- Formation des nouveaux engagés au module QUMAS pour les systèmes déviation, CAPA et Change control + flux associés.
QA/Production/service technique (AX, QUMAS), achats (qualification des fournisseurs) QC (release des matières premières, déviations, CAPA, Change control,…) et clients (réponses audits).
P rofil requis :
- Niveau Bachelier scientifique ou équivalent
- Expérience précédente de 3 ans dans un environnement GMP
- Maitrise des systèmes informatiques QUMAS, AX, LIMS,…
- Langue : français & Anglais, parlé, lu et écrit. Connaissance de l’anglais pour contact avec les autres sites Polypeptide (AX, gestion des fournisseurs,…)
- Utilisation de Microsoft Office
- Grande précision dans l’exécution des tâches
- Rigueur, organisation, flexibilité
- Excellent esprit d’équipe
PolyPeptide offre un environnement de travail dynamique et attrayant avec l'opportunité de travailler dans un contexte varié au sein du département spécifique. Chez PolyPeptide, nous oeuvrons ensemble pour former une même équipe.
Nous offrons un contrat à temps plein, un salaire attrayant assorti d'avantages extra-légaux, un poste stimulant dans un environnement innovant, dynamique et à forte progression.
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