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Open nowPosted today

Responsable Assurance Qualité Systèmes Informatisés / Data Integrity H/F

lfb88 open roles

Where
Arras, Hauts-de-France
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Your applicationOpen nowResponsable Assurance Qualité Systèmes Informatisés / Data Integrity H/Flfb · Arras, Hauts-de-France

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The clock on this job

Early applications get read.

13.5% of postings close within 7 days. Measured by our own scanner across the market. lfb postings stay open a median of 19 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.6%3 days
  3. 13.5%7 days
  4. 21.8%14 days
  5. 36.6%30 days
  6. 58.9%60 days
This job: posted today

lfb median: 19 days open

The posting

QUELLES MISSIONS VOUS SERONT CONFIEES ?

Sous la supervision de la Direction Qualité du site industriel d’Arras, vous êtes responsable pour le site de l'Assurance Qualité des Systèmes Informatisés et du programme Intégrité des Données (DI). A ce titre, vous managez une équipe de 3 personnes.

Dans ce cadre, vos missions se déclinent ainsi :

  • Piloter la performance de son équipe dans l’excellence et les valeurs de l’entreprise
  • Rédiger à partir des procédures corporate groupe les procédures locales du site (revue et approbation)
  • Animer et piloter les comités de pilotage Data Integrity du site
  • Participer et approuver les Data Integrity Risk Assessment (DIRA) et le plan de remediation associé
  • Suivre les CAPA de remédiation, communiquer les indicateurs et les réalisations au comité de direction et au Data integrity compliance officer groupe.
  • Rédiger le rapport Data integrity annuel du site
  • Présenter en audit et en inspection réglementaire les sujets DI du site
  • Participer au traitement des déviations relatives à des problèmes de DI
  • Participer aux réunions pluridisciplinaires sur les changements (DCI) de production et laboratoires pour veiller à la bonne intégration des aspects DI dans les URS et la validation
  • Proposer à la Direction les CAPEX liés à l’amélioration du niveau de compliance DI
  • Travailler en collaboration avec l’informatique Industrielle et la DSI sur les aspects DI
  • Elaborer et contribuer à la mise en place le plan data integrity du site, en lien avec le plan global Qualité DI groupe, et avec les priorités définies dans le plan qualité du site
  • Animer la préparation des Inspections réglementaire pour tous les sujets relatifs à l'intégrité des données
  • Etre le donneur d’ordre sur le budget DI du site

QUEL PROFIL POUR CETTE OPPORTUNITE ?

De formation Bac + 5 dans domaine scientifique ou qualité, vous justifiez au minimum de 10 années d’expérience sur des activités de Data Integrity et de validation des Systèmes Informatisés dans l’industrie pharmaceutique.

  • Connaissances des référentiels Qualité et réglementation en vigueur
  • Maîtrise des processus et outils Qualité : amélioration continue, déviations/CAPA/Change control
  • Gout pour la gestion de projets et le management transversal
  • Anglais courant

QUELS AVANTAGES LIES A CE POSTE ?

  • Poste à pourvoir en CDI
  • Accord de télétravail : jusqu’à 2 jours par semaine, dès 4 mois d’ancienneté
  • Jours de RTT + 3 jours de congés supplémentaires
  • Participation aux frais de transports
  • Avantages Groupe : mutuelle, prévoyance, CE, PEG/PERE-CO avec abondement, Compte Epargne Temps
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