Quality Assurance Manager
5 mesi fa
Per Società Pharma di rilevanza internazionale stiamo ricercando un/una:
**Quality Assurance Manager**
Inserito/a nel del dipartimento di “Quality Assurance”, riportando all’Head of Department, la figura ricercata garantirà l’attuazione delle politiche aziendali per la qualità e il rispetto delle normative/linee guida applicabili per tutte le attività nell’ambito della Ricerca e Sviluppo (R&S) e contribuirà alla prevenzione dei rischi legati alla qualità.
Avrà le seguenti responsabilità:
- **Documentazione - Quality System** (Implementazione normative nazionali e internazionali, garantire l’attuazione e l’aggiornamento della politica e della documentazione);
- **Formazione **(Fornire consulenza e supporto al personale di ricerca e sviluppo nell’implementazione del processo di formazione e creare/aggiornare materiale di formazione sulla qualità);
- **Prevenzione del Rischio** (Prevenzione Rischi Qualità in collaborazione con gli altri dipartimenti. Seguire l’implementazione delle Azioni Correttive e Azioni Preventive (CAPA). Partecipare alle ispezioni normative in ruoli di supporto. Assistere nella preparazione, esecuzione, preparazione delle risposte alle autorità sanitarie e follow-up);
- **Progetto di Sviluppo Clinico (Progetto S)**: In qualità di membro del team di studio R&S QA QMS: Partecipare al gruppo di studio, contribuendo all’identificazione del rischio, alla definizione delle misure di mitigazione e al mantenimento della strategia di prevenzione del rischio;
- **Assicurazione Qualità - Responsabilità nei Centri Internazionali di Ricerca Terapeutica (ICTR) ubicati negli Hub** (Valutazione degli indicatori di qualità, partecipazione alle ispezioni normative, responsabilità della competenza e della convalida dei requisiti normativi locali).
**Requisiti**:
- Laurea in discipline Scientifiche o Discipline Medico-Sanitarie;
- Esperienza da 2 a 4 anni nel Quality Assurance nel settore farmaceutico in ambiente GCP (buona conoscenza della normativa UE applicabile e delle normative locali per Italia - Francia e dei requisiti GCP);
- Eccellenti capacità di comunicazione verbale e scritta e ottime capacità analitiche;
- Capacità di lavorare bene in team o in modo indipendente e in grado di dare priorità al lavoro, gestire più progetti mantenendo la qualità e sostenere la conformità.
**Sede di Lavoro**: Roma
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