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Validation Lead
5 mesi fa
AGC Biologics, azienda leader nella Cell & Gene Therapy, sta ricercando un Validation Lead
**Attività principali**:
- Definizione della strategia per le attività di qualifica di equipment/ sistemi/ facility/ utilities con stesura del Validation Master Plan, Validation Plan, SLIA process, Validation Summary in accordo alle ISP Guidelines for Commissioning and Qualification, alle EU GMP Guidelines e alle US Guidelines;
- Supporto nella Gestione dei change control relativi a equipment/ sistemi/ facility/ utilities;
- Revisione dei documenti URS relativi a equipment/ sistemi/ facility/ Utilities;
- Condurre il processo di Risk Assessment per valutare l’impatto delle opere di costruzione sulla facility, sistemi, utilities e definire in collaborazione con Engeneering dept la strategia per la qualifica di equipment/ sistemi/ facility/ utilities ;
- Revisione di protocolli e report di qualifica per equipment/ sistemi/ facility/ utilities ;
- Revisione di lay-out e P&id.
**Requisiti**:
- Esperienza nel ruolo in azienda Farmaceutica di almeno 7 anni;
- Buona conoscenza della lingua inglese;
- Capacità di lavorare in team.
