Process Expert
3 settimane fa
:
IVREA
SPECIALIZZAZIONE:
Engineering
PROCESS EXPERT - PHARMA (ASEPSI)Il nostro cliente è un' radiofarmaceutica focalizzata sullo sviluppo di prodotti per la terapia mirata con radioligandi e l'imaging di precisione con radioligandiPrincipali responsabilità:
Il Process Expert Engineer fornirà supporto alla produzione, lavorando con i team di turno, concentrandosi sulla produzione di ogni lotto in modo conforme ai di qualità (Quality Risk Assessment, creazione di SOP di produzione e Master Batch Records):
Laurea in Ingegneria, Farmacia, Tecnologia Farmaceutica, Chimica o titolo scientifico equivalente;Esperienza mínima di 2 anni in ruoli legati all'Ingegneria di Processo, GMP e/o QA/QC.Esperienza in ambito validazioni (MS&T/produzione), investigazioni e deviazioni di processoPreferenziale la provenienza da aziende che lavorano in asepsi, radiofarmaceutiche o radiochimicheComprovata comprensione del processo (farmaceutico, GMP, aspetti normativi);Inglese - fluente scritto e parlato.Attività:
Agire come esperto in materia (PMI) per la conoscenza del prodotto e del processo, essere altamente informato sulle tendenze del prodotto e del processo fornendo inputad APQR per l'analisi e per guidare le innovazioni tecnologiche di processo.Raccogliere dati per la verifica del processo in corso (OPV), supportare il product steward nel monitoraggio e nella valutazione delle prestazioni del prodotto e nell'implementazione dei CAPA.Valutazione di prima linea dei problemi relativi al prodotto/processoSupporto del il product steward per le modifiche tecniche, analisi delle cause primarie, valutazione del rischio per la qualità, la strategia di controllo dei processi.Mantenere i processi a livello di preparazione all'ispezione.Supportare la definizione dell'ottimizzazione dei processi e l'introduzione di nuove tecnologie per il miglioramento continuo della produttività, a seconda dei casi.Convalida per il/i prodotto/i assegnato/i:
rivedere i protocolli e i rapporti di convalida per verificarne la correttezza técnica; supportare l'esecuzione delle convalide dei processi e dei progetti di miglioramento a breve termine, in collegamento con tutte le parti interessate in officina per garantire un'esecuzione accurata.Eseguire miglioramenti e scale-up del processo.Testare a fondo le variabili critiche.Località e offerta:
Ivrea (TO).L' offre un contratto a tempo indeterminato diretto e package retributivo parametrato alle competenze professionali.
Web:
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