Lavori attuali relativi a QA Floor Support Specialist - Florence, Toscana - Confidenziale

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QA Floor Support Specialist

3 mesi fa


Florence, Toscana, Italia Confidenziale A tempo pieno
Per il nostro stabilimento di Sesto Fiorentino siamo alla ricerca di risorse da inserire nei nostri reparti di produzione parenterale e di packaging con il ruolo di QA Floor Support Specialist. Le risorse riporteranno direttamente al QA Manager dellarea di riferimento e dovranno garantire il supporto tecnico/scientifico e di compliance di primo livello durante le attivit di produzione e che la documentazione dei Batch record sia conforme agli standard di qualit. Principali responsabilit del ruolo:
Garantire che le pratiche operative dei reparti di produzione assegnati siano in compliance con standard qualitativi aziendali ed in conformit alle GMP Eseguire troubleshooting su problematiche di processo, intervenire in seguito ad anomalie ed essere il primo riferimento in campo per la gestione difetti Eseguire la valutazione dei cicli macchina, degli allarmi di processo e di quelli relativi al reparto diproduzione Collaborare con i team di processo per linvestigazione di deviazioni e limplementazione di change Collaborare alla prepazione delle ispezioni Autorizzare la ripartenza della produzione dopo interventi di manutenzione straordinaria Supportare la scrittura delle procedure ed eseguire attivit di Batch review Svolgere il ruolo di osservatore durante lesecuzione del Media Fill Pu erogare training per SOP, corsi e QP/LV agli operatori di produzione Requisiti minimi richiesti Laurea Magistrale in discipline scientifiche (Chimica, CTF, Biologia, Biotecnologie, etc) Buona conoscenza della lingua inglese (livello minimo richiesto B2) Buona conoscenza del Pacchetto Office Conoscenza delle GMP e della produzione farmaceutica Requisiti aggiuntivi/preferenziali Capacit di team-working e di decision making Esperienza pregressa nel ruolo, maturata preferibilmente in contesti farmaceutici produttivi/ambito parenterale Si richiede la disponibilit a lavorare su turni, anche notturni. Per questa posizione previsto inserimento iniziale con contratto a termine.