qa manager fill

vor 1 Woche

YverdonlesBains, Waadt, Schweiz Recrutis Vollzeit CHF 90'000 - CHF 120'000 pro Jahr

Pendant que 90% de la biotech licencie ou gèle ses recrutements, Incyte développe son site d'Yverdon-les-Bains (investissement 100M CHF). Vous pilotez la qualification QA de la ligne de remplissage aseptique, puis assurez l'excellence opérationnelle en production stérile.

POURQUOI CE POSTE AUJOURD'HUI

  • Croissance rare en biotech : L'un des rares sites européens en phase d'expansion avec investissements confirmés
  • Double mission stratégique : Qualifier la ligne Fill & Finish (FAT/SAT, IOPQ, commissioning) puis piloter les opérations GMP aseptiques
  • Site ultra-moderne : Campus 13'300 m² inauguré en 2021, équipements de dernière génération, technologies isolateurs/RABS
  • Stabilité Suisse : Big pharma US investit sur le long terme, visibilité garantie (vs incertitude Europe)

VOTRE RÔLE CONCRET
Phase projet : Vous assurez l'oversight QA de la qualification de la ligne de remplissage aseptique (salles blanches, isolateurs, utilities). Vous validez les activités FAT/SAT/IOPQ, intégrez les principes Annex 1 dès la conception, menez les évaluations de risques qualité.

Phase opérationnelle : Vous pilotez les activités QA liées à la production aseptique (revue SOPs/batch records, management déviations/CAPAs, préparation inspections FDA/EMA), garantissez la compliance GMP et Annex 1.

PACKAGE

  • Attractif, selon expérience
  • Contrat permanent, site Yverdon-les-Bains (Suisse romande, 1h de Lausanne/Genève)
  • Formation continue, projet structurant avec visibilité management
  • Big pharma US en croissance = évolution de carrière garantie

PROFIL RECHERCHÉ
✓ Expérience significative en qualification, validation et opérations GMP ✓ Expérience aseptic processes (technologies isolateurs = atout majeur) ✓ Expérience oversight QA de projets pharmaceutiques (engineering + manufacturing) ✓ Diplôme académique sciences naturelles/appliquées (Pharmacie, Chimie, Biotech, Ingénierie) ✓ Connaissance approfondie cGMP, Eudralex Annex 1, Sterility Assurance ✓ Français courant oral/écrit (Anglais professionnel = atout)

Réponse sous 48h.

Recrutis accompagne Incyte dans ce recrutement stratégique.

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