Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients
Product batch release
At a glance
Our teams produce and deliver over 4 billion units of medicines and vaccines every year, ensuring every breakthrough gets to the people who need it most.
Our state-of-the-art facilities, AI-powered smart factories, and cutting-edge automation are redefining what’s possible: ensuring treatments reach patients faster, safer, and more sustainably than ever before. This is where your skills, ambition, and passion can shape the future of healthcare.
Objectif/Délivrable :
- Participer aux processus Qualité,
- Etre support pour les processus Qualité impliqués,
- Assurer une présence terrain et participer d’une manière active à la résolution des dysfonctionnements AQ dans son secteur.
Les principales tâches sont les suivantes :
- Rédaction d’analyse de risques, protocoles et rapports de validation,
- Revue des dossiers lots,
- Rédaction de batch-abstracts sur les différents lots produits,
- Gestion des déviations en lien avec les produits concernés, Rédaction de rapport de déviations significatives, de réclamations,
- Gestion des Change Control en lien avec les projets suivis,
- Libération de lots de principes actifs et d’intermédiaires de synthèse, réception/libération des matières premières,
- Participation aux audits et inspection, à la relecture BLA, aux réponses aux questions dans le cadre de soumissions règlementaires.
- Communication et échange d’informations avec des tiers,
- Rédaction des revues annuelles produit/utilités/environnement,
- Enregistrement de la documentation partagée avec les tiers (Feuille de fabrication, Rapport de déviation, Change Control, Rapport de validation, Revue Produits, …)
- Gestion des actions associées dans l’ERP
- Expertise en validation de nettoyage de produits biotechnologiques,
- Rédaction de la documentation de validation de nettoyage : protocole et rapports, suivi du déroulement du protocole et gestion des anomalies,
Profil : Bac +5 qualité ou profil ingénieur avec expérience sur site industriel
Langue(s) de travail/ rédaction : Français et Anglais (C1)
Savoir être et savoir-faire :
- Connaissances des GMP, Connaissance Production et Laboratoire Biotechnologies appréciée
- Connaissance des règlementations ICH Qualité et des guides internationaux Qualité
- Esprit d'analyse et de synthèse
- Forte rigueur et méthode
- Esprit d'équipe
- Bonne capacité rédactionnelle
- Adaptabilité
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.
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Why work with us
- We’re problem-solvers and pioneers. United by the belief that everyone deserves a healthier future. We create best-in-class vaccines that prevent disease and protect lives.
- Innovation drives us. From AI and mRNA to next-gen science, we push the boundaries to deliver first- and best-in-class vaccines for infectious diseases worldwide.
- Growth happens here. With bold investments in R&D and world-class facilities, Sanofians across the entire vaccine lifecycle are shaping the future of global health.
- We do what’s right. Sustainability and DE&I drive our positive global impact—because the diverse communities Sanofians represent are the patients we serve.
All-in on diversity
At Sanofi, diverse perspectives fuel the best solutions for patients. Hear from Monique Vessey, our Supply Chain Transformation Leader, on how her background shapes her approach to delivering life-changing medicines.
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What could we achieve together? Every Sanofian works on projects that truly make a difference to people’s lives.
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