- D'assurer la conformité aux réglementations en vigueur (BPF, 21CFR part 11, annexe 11) et aux procédures groupe/locales concernant la validation des systèmes informatisés du site (conformité des nouveaux systèmes informatisés et maintien du statut validé), incluant la revue et approbation des documents de qualification, revue et approbation des revues d'audits trails, revues/approbation des revues d'accès, back-up and restore,...
- De réaliser des analyses de risques avec les system owner/data owner des systèmes informatisés et mettre en œuvre des plans de mitigations
- D'être le partenaire privilégié des System owner/data owner des systèmes informatisés
- De revoir/approuver les déviations/ changements et CAPA liés aux systèmes informatisés et/ou intégrité des données
- D'assurer la conformité aux réglementations concernant l'intégrité des données (bonnes pratiques documentaires, archivage de la documentation) en collaboration avec les équipes AQ opérationnelles et QMSC
- De guider les équipes sur site en ce qui concerne les exigences en matière d'intégrité des données
- D'être l'expert répondant aux questions relatives à l'intégrité des données/validation des systèmes informatisés lors des inspection réglementaires, audits clients ou audits internes
- De collaborer au sein du groupe et en externe pour mettre en place les bonnes pratiques liées à l'intégrité des données/CSV et assurer la veille réglementaire sur ces thématiques
- D'auditer la validation des systèmes informatisés/intégrité des données des fournisseurs/ sous-traitants et en interne
- Master/Ingénieur (sciences de la vie, chimie, engineering) ou pharmacien
- Minimum 8 ans d'expérience dans l'industrie pharmaceutique
- Expertise dans la validation des systèmes informatisés, 21CFR part 11, annexe 11, intégrité des données, GAMP5
- Expérience dans la revue/approbation de documents de validation
- Expérience probante dans le déploiement de systèmes informatisés de fabrication et/ou de laboratoire dans un environnement BPF
- Excellente communication écrite et orale (en français et en anglais)
- Pédagogie/capacité opérationnelle/esprit orienté résolution des problèmes, incluant la capacité à détecter les défaillances, planifier/organiser les tâches et les réaliser
- Capacité à travailler en équipe/de manière transverse
- Capacité à travailler sur plusieurs projets simultanément
- Expérience d'audits/inspections : présentation de sujets lors d'inspections/audits clients
- Expérience en tant qu'auditeur interne/externe
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Data Integrity Officer - Strasbourg, France - Polypeptide Laboratories France Strasbourg, France
Description
PolyPeptide Laboratories France à Strasbourg est la filiale française d'un groupe international d'environ 1 200 personnes, leader mondial dans son domaine d'activité. Nous développons des procédés de fabrication de chimie fine et fabriquons des principes actifs à usage pharmaceutique.
Nous recherchons pour le site de Strasbourg, dans le cadre d'un contrat à durée indéterminée un(e) :
Data Integrity Officer / Expert validation des systèmes informatisés
Au sein de département Assurance Qualité, rattaché(e) hiérarchiquement à la Directrice Assurance Qualité, votre rôle sera :
Profil recherché :
Poste à pourvoir dès que possible
