QA Projects C&Q Associate
il y a 2 semaines
Associate Assurance Qualité Q&C– Equipements Analytiques
Just-Evotec Biologics recherche un Associate QA Q&C – Equipements analytiques qui recherche une opportunité pour améliorer mondialement l'accès aux biothérapies.
Dans le cadre du projet de construction d'un site de fabrication de biomédicaments, rattaché au responsable Assurance Qualité Projets au sein du groupe Assurance Qualité Ingénierie et Validation, vous contribuez à l'application des Bonnes Pratiques de Fabrication au travers des processus de qualification des équipements.
A ce titre, vous serez amené.e à :
Revoir la documentation rédigée par nos partenaires pour les équipements de nos trois laboratoires de contrôle qualité : Laboratoire de microbiologie : Laboratoire de Physico-Chimie Laboratoire de Bioassay.Les équipements dont vous aurez la charge seront adaptés à votre profil : Chaînes HPLC, Lecteur de plaques, Incubateurs, Pipettes, Congélateurs, Réfrigérateurs, Pompes de bioburden etc.
La documentation que vous reverrez seront : des protocoles de tests, des protocoles exécutés, des rapports, etc.
Effectuer le suivi des déviations sur les équipements de votre secteur. Selon votre profil, vous pourrez être amené à suivre la mise en place de plan d'action ou de change control ou la revue de procédure. Assurer le reporting de votre périmètre auprès de votre supérieur hiérarchiqueFormation / Profil
Vous êtes titulaire d'un bac+2/3, orienté qualité ou laboratoire. Vous avez idéalement une expérience opérationnelle réussie (y compris stage ou alternance) en qualification. Vous connaissez les Bonnes Pratiques de Fabrication partie I & II, et particulièrement des annexes 1 et 15. Une formation et/ou une expérience dans le domaine de la bioproduction est un atout. Vous êtes volontaire, dynamique, avez de bonnes qualités relationnelles et avez l'esprit d'équipe. Vous êtes à l'aise avec l'anglais à l'écrit. Ce serait un atout d'être à l'aise à l'oral.Quality Assurance Q&C Associate – Analytical Equipments
Just-Evotec Biologics is seeking a motivated Quality Assurance Q&C Associate– Analytical Equipments that desires a significant opportunity to improve worldwide access to biotherapeutics.
As part of the project to build a biomedicines manufacturing site, reporting to the Project Quality Assurance Manager within the Quality Assurance Engineering and Validation group (QEV), you will contribute to the application of Good Manufacturing Practices through the equipment qualification.
As such, you will be required to:
Review the documentation written by our partners for our 3 Quality Control Laboratories : Microbiology Lab Physico Chemistry Lab Bioassay LabYou will oversee several equipment according to your profile. Equipment can be : HPLC, COT metre; Incubators, Pipets, Freezer, refrigerator, bioburden pumps, etc.
The documentation to be reviewed are : protocols, executed protocols, reports, etc.
Follow-up of deviations on equipment you have in charge. According to your profile, you can be involved in CAPA plan, Change Control and/ or SOP review. Reporting on your area of responsibility to your line manager.Position Requirements
You have a technical degree, preferably oriented quality, or laboratory. You have ideally a first successful operational experience (including sandwich course or internship) In qualification. You have a knowledge of Good Manufacturing Practices Part I & II and particularly appendix 1 and 15. Training and/or experience in biomanufacturing would be an asset. You are volunteer, dynamic with good relationship qualities and have a very good team spirit. You have a good writing English level. Having a good speaking English would be an asset.About Just – Evotec Biologics
Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 150+ employees is expanding Just's innovative platform and footprint - building our first North American J.POD commercial manufacturing facility in the Seattle area. For job opportunities, learn more at
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
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