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Technicien AQ Process USP/DSP / USP/DSP QA process technician – All genders Job Opening In Toulouse – Now Hiring Just - Evotec Biologics EU


Job description

Mission générale /


Dans le cadre du démarrage et de l’exploitation d’une usine de production biotechnologique, Just-Evotec Biologics recherche un technicien AQ Process USP/DSP pour rejoindre une équipe dynamique, collaborative et multidisciplinaire.

Sous l’autorité de la responsable du département Assurance Qualité Produits au sein du groupe Assurance Qualité Process, vous assurerez la revue des dossiers de lot de production issus des préparations de milieux et de tampons ainsi que des processus upstream et downstream (UPS / DSP).

Vous évoluerez dans un cadre règlementé par les Bonnes Pratiques de Fabrication sur notre site de Toulouse.



Responsabilités et missions /
 

A ce titre, vous serez amené(e) à :

  • Participer à la revue des dossiers de lot de production (incluant la communication avec la production).

  • Participer à la compilation des données et à la rédaction des Revues Qualité Produit (RQP).

  • Participer à la revue et au suivi des événements qualité (analyse de risques, déviations, CAPA et change controls).

  • Participer à la réalisation des analyses de récurrence et de tendance relatives à la surveillance et maîtrise des produits et processus de production ; Suivi des indicateurs de performances.

  • Maintenir la documentation qualité du secteur en tant que rédacteur ou vérificateur.

  • Détecter et remonter les problèmes qualité via les processus internes.

  • Proposer des axes d’amélioration.

  • Aider à la préparation des inspections réglementaires liées aux activités AQ Produits.

  • Connaissances et compétences /

  • Connaissances des BPF (théorique et expérience pratique).

  • Compétences en communication (à l’oral et par écrit) et capacités relationnelles.

  • Capacité à évaluer la conformité des processus de production mis en œuvre.

  • Aisance avec l'outil informatique.

  • Anglais professionnel (écrit/oral).

  • Pragmatisme, réactivité et rigueur.

  • Expérience et formation /

  • Vous êtes titulaire d’un Bac +2/3 avec une spécialisation en Assurance Qualité dans le domaine pharmaceutique.

  • Environ 5 ans d'expérience en Assurance Qualité ou en Production dans l'industrie pharmaceutique / biotechnologique.

  • Dans l’idéal, expérience en revue de dossiers de lots (papier et/ou électronique) en pharmaceutique ou en bio-industrie.

  • Autres informations /

    CDI /

    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.

    Required Skill Profession

    Other Production Occupations


    • Job Details

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