Quality Raw Material

3 settimane fa


Milano, Italia AGC Biologics A tempo pieno

**Attività principali**:

- Fornire supporto alle attività di qualifica e monitoraggio periodico dei fornitori di materiali e servizi;
- Redigere i report di audit dei fornitori di materiali e servizi;
- Eseguire le quality review periodiche dei fornitori;
- Gestire i Quality Agreement con i fornitori di materiali e servizi e i relativi reclami;
- Gestire le change notification ricevute dai fornitori;
- Gestire change/deviazioni e CAPA in cui sono coinvolti aspetti legati ai fornitori;
- Fornire supporto nella gestione delle attività di audit esterno;
- Fornire supporto per l'integrazione alle policy corporate per la gestione dei fornitori;
- Emettere / Revisionare le SOP di area;
- Fornire supporto nella preparazione delle ispezioni di clienti e di ispezioni regolatorie, e nella definizione di CAPA in seguito a deviazioni riscontrate durante le suddette ispezioni.

**Requisiti**:

- Laurea in ambito scientifico;
- Esperienza di almeno 3 anni in industria farmaceutica con produzione di sterili;
- Preferenziale la certificazione di Lead Auditor;
- Buona conoscenza della lingua inglese.


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