Lead Technician

6 giorni fa

Sesto Fiorentino, Toscana, Italia Eli Lilly and Company A tempo pieno 34.000 € - 68.000 € all'ano

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 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.

Percorso/Livello
Per il nostro stabilimento di Sesto Fiorentino, siamo alla ricerca di un/a
QA floor Support Sr Specialist
che garantisce il supporto tecnico/scientifico e di compliance di primo livello alle operation (sia formulation che filling) nel corso delle attività di produzione ed effettua il monitoraggio ambientale relativo alle superfici degli isolatori/RABS di produzione.

PRINCIPALI RESPONSABILITA'

  • Controlla il rispetto delle pratiche operative in riferimento alle procedure vigenti
  • Esegue la valutazione dei cicli macchina e degli allarmi di processo.
  • Effettua il Process monitoring.
  • Autorizza la ripartenza della produzione dopo interventi di manutenzione straordinaria.
  • È il primo contatto in campo per la gestione dei difetti guanti, leak.
  • Esegue il training agli operatori di produzione.
  • Svolge il ruolo di osservatore durante l'esecuzione del Media Fill.
  • Può supportare la scrittura delle procedure.
  • Può eseguire attività di batch review.
  • Esegue campionamenti di RTS degli equipment di produzione.
  • Segue correttamente le correnti procedure per il campionamento microbiologico delle superfici degli Isolatori/RABS di produzione e la gestione dei relativi allarmi.
  • Utilizza il sistema MODA per la gestione dei dati relativi ai campionamenti microbiologici delle superfici.
  • Partecipa alle investigazioni degli eventi e risultati analitici sospetti.
  • Gestisce gli allarmi QBMS relativi ai parametri critici del sistema HVAC, PCA e frigo e freezer del reparto di produzione.
  • Può eseguire il campionamento microbiologico delle aree classificate e la gestione dei relativi allarmi. Può eseguire la lettura dei campionamenti EM e controllare che i risultati ottenuti siano conformi ai limiti registrati riportati nelle procedure di riferimento, notificando eventuali fuori limite, trends e risultati analitici sospetti

QUALIFICHE RICHIESTE

  • Laurea magistrale
  • Conoscenza delle GMP e della produzione farmaceutica
  • Buona conoscenza della lingua inglese e del pacchetto office
  • Propensione e capacità nel lavoro di gruppo
  • Capacità di problem solving e decision making

Per questa posizione è previsto inserimento con contratto iniziale a termine.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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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