Compliance & Quality System Manager

3 mesi fa

Ivrea, Italia Novartis A tempo pieno

**Summary**:
~Gérer les activités, opérations et systèmes rentables de conformité GxP et/ou d’audit pour assurer la conformité des secteurs d’activité avec le manuel et les politiques de qualité de Novartis et toutes les exigences GxP, légales et réglementaires pertinentes, et par le biais d’audits internes, d’indicateurs clés de performance (indicateurs clés de performance) et de KQI (indicateurs clés de qualité)
~ Diriger la préparation et la gestion des audits externes et corporatifs et des inspections des autorités sanitaires.

**About the Role**:
Major Accountabilities

~ Surveillance et mise en œuvre du système de gestion de la qualité
~ Gestion des incidents.
~ Gestion de l’audit et de l’inspection de GxP
~ Surveillance réglementaire du site (y compris la facilitation reg-CMC)
~ Gestion des exceptions
~ Gestion de la qualité des fournisseurs (local)
~ Qualification et validation
~ Conformité qualité
~ Intégrité des données et eCompliance
~ Site KPI / KQI maintenance / reporting
~ Initier et stimuler le processus d’embauche local
~ Responsabilité en ligne et procédure pas à pas quotidienne
~ Lead OpEx Projects
~ Enquête sur la déviation, OOx, Plaintes
~ Définir et mettre en œuvre les APA
~ Soutenir les projets de transfert et les études de validation
~ Suivre les mesures de l’équipe et s’assurer que KQI/KPI répond aux exigences
~ Examiner et approuver le texte et la conception
~ Signalement des incidents HSE et suivi des actions
~ Nouveaux équipements de mise en service (OQ, PQ)
~ Définir les domaines d’amélioration des processus et des produits
~ Planification des ressources et de la capacité (personnes et équipement) et gestion de la charge de travail
~ Soutien à la performance et au leadership de l’équipe de spécialistes
~ Assurer la disponibilité de l’équipement, des produits chimiques et des consommables, le cas échéant
~ Examen et révision des POS
~ Effectuer une formation locale et surveiller l’état de la formation
~ Déclaration des plaintes techniques / événements indésirables / scénarios de cas particuliers liés aux produits Novartis dans les 24 heures suivant leur réception
~ Distribution d’échantillons de commercialisation (le cas échéant)

Key Performance Indicators

~Gérer les activités, opérations et systèmes rentables de conformité GxP et/ou d’audit pour assurer la conformité des secteurs d’activité avec le manuel et les politiques de qualité de Novartis et toutes les exigences GxP, légales et réglementaires pertinentes, et par le biais d’audits internes, d’indicateurs clés de performance (indicateurs clés de performance) et de KQI (indicateurs clés de qualité)
~ Diriger la préparation et la gestion des audits externes et corporatifs et des inspections des autorités sanitaires.

Work Experience

~Étendue fonctionnelle
~People Leadership
~Collaborer par delà les frontières
~Gestion de projet

**Skills**:
~Gestion des incidents majeurs
~Audit
~Audits de conformité
~Évaluations du rendement des employés
~Gestion du personnel
~QA (Assurance Qualité)
~Procédures BPF
~Autorités sanitaires
~Prise de risque intelligente
~Sens aigu des finances
~Faire face à l'ambiguïté
~Conscience de soi
~Apprentissage continu
~Expertise technologique
~Compétences en matière de prise de décision
~Collaboration / Travail d'équipe
~Compétences en communication
~Compétences en résolution de problèmes
~Orienté vers les objectifs
~Pensée logique
~Leadership
~Agilité
~Partenariat d'affaires
~Sens des affaires
~Gestion des parties prenantes
~Compétence en résolution de problèmes

Language

Anglais

Division

Operations

Business Unit

Innovative Medicines

Location

Italy

Site

Ivrea

Company / Legal Entity

IT58 (FCRS = IT058) AAA Italy Srl.

Functional Area

Quality

Job Type

Full time

Employment Type

CDI

Shift Work

No

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