FR - Auvergne-Rhône-Alpes - Lyon
December 9, 2024
Chargé(e) de Validation des Systèmes Informatisés F/H Audensiel Healthcare, jeune entreprise innovante, est née de la volonté d'apporter de l'expertise et de la réactivité à ses clients des secteurs de l'industrie Pharmaceutique, des Biotechnologies et des Dispositifs Médicaux.
Notre cabinet d'ingénierie et de conseil, société à taille humaine, a pour mission de contribuer à l'amélioration de la productivité de nos clients, à travers des expertises métiers complémentaires : Ingénierie et travaux neufs, Commissioning, Qualification / Validation, Affaires réglementaires, Assurance Qualité, Excellence opérationnelle.
Fiers de nos valeurs, nous avons été récompensés par le label « Great Place to Work », synonyme de bien-être de nos collaborateurs et de nos engagements envers eux.
Dans le cadre du développement de nos activités, Audensiel Healthcare recherche un(e) Chargé(e) de Validation des systèmes informatisés pour son agence à Lyon.
En tant que consultant Audensiel Healthcare, vos missions seront de résoudre les problématiques de nos principaux clients et d'apporter votre savoir-faire.
Vous interviendrez pour un grand acteur de l'industrie pharmaceutique en support à la production afin de :
Mettre en place la stratégie de validation système SI d'archivage et restauration de données
Rédiger les protocoles de validation
Organiser les tests avec les services transverses (production, maintenance. ) et superviser les tests
Rédiger les rapports de validation
Votre profil Compétences attendues :
Sens du travail en équipe
Connaissance du GAMP et du 21 CFR part 11
Qualité rédactionnelle
Autonomie, disponibilité, bon relationnel
Capacité d'intégration et d'adaptation
Diplômé(e) d'une Ecole d'Ingénieur, d'un équivalent bac+5 ou d'une Faculté de Pharmacie, orientée management de la qualité, qualité du médicament, maitrise des risques qualité.
Vous justifiez d'une expérience de 2 ans minimum dans des fonctions similaires sur un site de production pharmaceutique.
Vous souhaitez intégrer notre « Lab d'excellence » qui valorise ses collaborateurs au travers d'un management de proximité et d'un réseau d'experts : Venez nous rencontrer et participer au développement de notre stratégie !
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