Quality System Manager
1 giorno fa
**Agc Biologics, azienda leader nel Cell & Gene Therapy, sta ricercando un Quality System Manager.**
**Attività principali**:
- Coordinare le attività dell'unità Quality System e le risorse ad essa assegnate;
- Collaborare con la Direzione per la gestione degli investimenti, delle risorse e la preparazione dei budget di propria competenza;
- Supportare la Direzione nell'organizzazione dei Management Review meeting di sito;
- Garantire la compliance del QS del sito ai requisiti regolatori e agli standard/ policies delle Corporate;
- Partecipare attivamente a progetti Corporate inerenti il Quality System;
- Garantire che il Site Master File sia sempre aggiornato;
- Definire le misure da applicare per garantire il data Integrity;
- Garantire che le procedure operative e la documentazione siano conformi ai requisiti regolatori ed alle policies del QS;
- Garantire l'applicazione del processo di Quality Risk Management;
- Gestire il processo di change control, CAPA e training definendone i flussi e le responsabilità;
- Pianificare e gestire gli audit dei clienti e delle autorità regolatorie;
- Fornire supporto nella preparazione della documentazione necessaria per la definizione delle CAPA in seguito ad ispezioni e audit;
- Pianificare e gestire gli audit interni (self inspection);
- Eseguire le Quality Review di change, CAPA e training;
- Definire con la Direzione gli obiettivi e i KPI di area.
**Requisiti**:
- Laurea in Biotecnologie/CTF o similari;
- Esperienza in un ruolo analogo in industria farmaceutica di almeno 5 anni;
- Esperienza nel coordinamento di risorse;
- Buona conoscenza della lingua Inglese;
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