Join an international team that accelerates drug discovery and development through scientific excellence and integrated CRO/CDMO solutions — helping our partners Dans le cadre de nos activités pharmaceutiques, nous recherchons un(e) Technicien assurance qualité – Biotechnologies pour rejoindre le site de Nuvisan France. Activités pharmaceutiques : Revue des dossiers relatifs aux lots de substances médicamenteuses/médicaments pour les produits commerciaux (médicaments à usage humain) dans l'UE/EEE et sur les marchés d'autres pays, et en particulier sur des médicaments de biotechnologie. Vérification de la pertinence des informations réglementaires requises en rapport avec l'autorisation de mise sur le marché. Revue et interprétation des déviations en rapport avec la fabrication de produits de biotechnologie. Mise en place d'un système de management de la qualité : Apporte son support et son expertise en matière de gestion de la qualité aux opérations. Contribue à la mise en œuvre et au suivi du système de gestion de la qualité. Pilote/accompagne les activités d'optimisation des processus. Contribue à la mise en œuvre et à l'exploitation des outils d'approche qualité et des résultats d'audit, ainsi qu'aux actions correctives. Contribue à la mise à jour des procédures opérationnelles standard (SOP). Fournit une interprétation des textes réglementaires et une analyse d'impact. Audits et Inspections : Effectue une revue des documents (plans, protocoles, rapports, documents réglementaires, etc.) Effectue des audits externes des fabricants des médicaments commerciaux. Rédige des rapports d'audit, recommande des actions correctives le cas échéant et assure un suivi approprié. Effectue un examen par les pairs des rapports d'audit rédigés par d'autres personnes et rend compte de tout problème majeur ou non-conformité. Autres activités : Apporte conseil et support en matière de microbiologie pour les opérations de Nuvisan France. Contribue à la qualification/validation des installations, des équipements et des systèmes. Compétences requises BAC+2 en Biotechnologies Au moins 3 ans d’expérience en tant que technicien en production pour des médicaments de biotechnologie Anglais lu, parlé, écrit At Nuvisan, everything revolves around one central question: How can we bring new therapeutics to the patients who need them faster? As a science-driven CRO/CDMO, we support the full spectrum of drug discovery and development. To succeed, we rely on people who are curious, take ownership and want to make a meaningful impact as part of a team. If you are looking for an environment that combines scientific excellence, collaboration and real opportunities to grow, you have come to the right place. Everyone Matters As part of ALS, Nuvisan is proud to be an equal opportunity employer and is committed to fostering an inclusive work environment where the strengths and perspectives of each employee are both recognised and valued. Nuvisan welcomes applications from people with all levels of ability. Reasonable adjustments to support candidates throughout the recruitment process are available upon request Eligibility To be eligible to work at Nuvisan you must be a citizen or permanent resident of the country you are applying for, or either hold or be able to obtain, a valid working visa. How to apply Please apply online and upload your detailed resume. We will contact you as soon as possible after reviewing your application. Your partner of choice in bringing therapeutics to life Nuvisan is a full-service contract research organisation (CRO) and development and manufacturing organisation (CDMO) with state-of-the-art laboratories in Germany and France. Our pharmaceutical, biotechnology, venture capital and non-profit clients partner with us because our high-quality end-to-end solutions and scientific expertise enable us to streamline and accelerate drug discovery and development – from ensuring target understanding to helping bring therapeutics to life. Founded over 40 years ago by a team of pharma industry innovators, Nuvisan has established a reputation for expertise and professionalism. Our team leaders have extensive experience in the biopharma industry, and our unique centres of excellence – for drug discovery in Berlin, formulation and GMP manufacturing in Sophia Antipolis, and our bioanalysis hub in Neu-Ulm – enable our experienced scientists to help guide and advance projects. We know how to discover, develop and bring the next generation of medicines to market. At the same time, we are committed to flexibility, transparency and collaboration in our approach, working closely with you to adapt to your individual needs, minimise risks and help deliver your project. Didn’t see the right job for you today? We'd still love to hear from you. With a team of more than 20,000 employees across 70 countries, it takes all kinds of skills and expertise to make a company like ours thrive – and not all of them are in labs! We’re all about people – so show us who you are and why you're passionate about working with us by submitting your resume, and we’ll keep it on file for future opportunities. Want to know more? Check out our careers page to find out about the benefits of joining our team, and don’t forget to follow us on LinkedIn for the latest updates!

Technicien assurance qualité – Biotechnologies.

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