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Sesto Fiorentino

    Quality Assurance Associate - Sesto Fiorentino, Italia - Lilly

    Lilly
    Lilly Sesto Fiorentino, Italia

    Trovato in: Talent IT C2 - 5 giorni fa

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    A tempo pieno
    Descrizione

    We're looking for people who are determined to make life better for people around the world.

    Il Quality Assurance Associate assicura che vengano applicate correttamente le cGMP e gli standard Lilly nella sua area. E' responsabile della gestione delle problematiche Quality all'interno del proprio Process Team nel Modulo Insulina. Le responsabilità possono variare in funzione del livello di autonomia e complessità crescenti.

    Responsabilità principali

  • Esegue la Batch Disposition dei lotti di prodotto semifinito (cartucce o siringhe pre-riempite)
  • 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
  • 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 dell'area Formulazione, Riempimento e Ispezione visiva
  • 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
  • Può avere la responsabilità di Departimental RIM steward
  • Requisiti minimi

  • Laurea magistrale ad indirizzo tecnico-scientifico (e.g. Chimica, Biologia, CTF, Ingegneria)
  • Ottima conoscenza della lingua Inglese
  • Esperienza nell'ambito della produzione e/o assicurazione qualità in azienda farmaceutica, preferibilmente in ambito parenterale
  • Altre competenze desiderate

  • 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.

    #WeAreLilly


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