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Quality Assurance Associate
1 mese fa
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Eli Lilly Italia, per lo stabilimento di Sesto Fiorentino (FI) è alla ricerca di una figura da inserire nel ruolo di Quality Assurance Associate.
La risorsa, riportando direttamente all’Associate Director dell’area di riferimento, sarà responsabile della corretta applicazione delle cGMP e degli standard Lilly nella sua area, oltre che della gestione delle problematiche Quality all’interno del proprio team cross-funzionale.
Responsabilità principali:
- Esegue la Batch Disposition dei lotti di prodotto semifinito
- Partecipa alla preparazione delle ispezioni da parte degli enti regulatory e supporta il programma delle self-inspection
- Esegue l’assessment e può investigare le deviazioni di processo.
- Approva le SOP di Livello 3 e può essere istruttore di training
- Contribuisce alla stesura dei documenti di valutazione periodica (APR e AQMS).
- Può svolgere il ruolo di osservatore durante l’esecuzione del Media Fill.
- Gestisce le attività di analisi per problemi di qualità e contribuisce all’analisi per problemi sterility assurance della propria area.
- Esegue l’assessment e può autorizzare l’implementazione dei change del reparto di appartenenza
- Esegue il process monitoring per la parte Quality
- Autorizza la ripartenza dopo gli shutdown dell’area
- Può approvare gli ODL straordinari
Requisiti minimi:
- Laurea Magistrale ad indirizzo tecnico-scientifico (e.g. Chimica, Biologia, CTF, Ingegneria)
- Inglese fluente
- Dimostrata capacità di team work, problem solving e decision making
Altre competenze desiderate
- Esperienza nell’ambito della produzione e/o assicurazione qualità in azienda farmaceutica, preferibilmente in ambito parenterale
- Conoscenza delle cGMP
- Capacità di integrarsi in un team cross-funzionale con focus sui risultati di squadra
- Capacità di problem solving e decision making
- Capacità di influenzare altri e comunicare in maniera efficace
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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