Operational Quality Expert

6 giorni fa

Milano, Italia AGC Biologics A tempo pieno

**AGC Biologics SpA, azienda leader nel Cell& Gene Therapy sta ricercando un Operational Quality Expert**

**Attività principali**:

- Gestione deviazioni relative agli aspetti di processo produttivo e metodi analitici;
- Eseguire le attività di batch record review;
- Redigere product specification file/similari;
- Partecipare attivamente alle ispezioni da parte di clienti e da parte degli enti regolatori supportando il Lead dell'unità;
- Preparare la documentazione per l'approvazione e il rilascio dei lotti di prodotti;
- Seguire le attività di area relative alla spedizione dei prodotti finiti;
- Coordinare le attività di area relative alla revisione ed emissione dei Master batch record;
- Predisporre la documentazione necessaria alle attività produttive di lotto prodotto;
**Requisiti**:

- Laurea in CTF/Biotecnologie o similari;
- Esperienza pregressa nel ruolo in ambito di produzione di prodotti sterili;
- Capacità analitica e proattività;
- Buona conoscenza della lingua inglese.

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