Lavori attuali relativi a Manufacturing Quality Specialist - Monza - Thermo Fisher Scientific

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Manufacturing Quality Specialist

4 settimane fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

Lo stabilimento produttivo di Monza è un centro di eccellenza globale per quanto riguarda le produzioni di farmaci sterili conto terzi. Entrerai a far parte di un team di oltre 1900 colleghi in un ambiente giovane, dinamico e fortemente orientato all'obiettivo. Con un fatturato di oltre 35 miliardi di dollari e i più grandi investimenti in R&D del settore, Thermo Fisher Scientific fornisce alle persone le risorse e le opportunità per contribuire in maniera significativa al raggiungimento del nostro obiettivo: aiutare i nostri clienti a rendere il mondo un luogo più sano, pulito e sicuro.

Entrerai a far parte dell’unità dedicata alla produzione di lotti clinici (PDS, Pharmaceutical Development Service) e affiancherai direttamente i Team Leader e Supervisore del reparto produttivo per contribuire ad una efficace gestione delle attività secondo le GMP. Collaborerai strettamente con la Quality Unit, in un contesto molto dinamico e internazionale. In particolare, ti focalizzerai sulle seguenti attività:

- Collaborazione con il team Quality Operation per una gestione tempestiva delle deviazioni e assicurare la consegna dei lotti nei tempi previsti
- Gestione delle CAPA, analisi root cause e programmi di miglioramento dei processi per evitare deviazioni ricorrenti
- Preparazione e gestione SOP relative a nuovi formati e prodotti
- Monitoraggio dei KPI relativi alla qualità
- Gestione audit dei clientiStudi/Diploma/Corsi di formazione:
Requisiti
- Laurea in CTF, biotecnologie o similari
- Consolidata esperienza in ambito Quality Assurance Operations (ad es. gestione investigazioni e CAPA) o esperienza in ambito Manufacturing di produzioni sterili
- Approfondita conoscenza delle cGMP, e gestione delle SOP di un reparto produttivo.
- Forti capacità comunicative e di coordinamento tra vari interlocutori
- Conoscenza dell’inglese e dell’italiano