Quality Assurance Specialist

1 giorno fa


Monza, Lombardia, Italia Randstad A tempo pieno
Quality Assurance Specialist

Randstad Inhouse Services, divisione di Randstad Italia spa, ricerca un esperto qualità per seguire la produzione farmaceutica su 3 turni di un'importante azienda multinazionale terzista nel settore.

In base alle indicazioni del Quality on the Floor Team Leader e del Quality Operations Manager, la risorsa si occupa della revisione dei lotti GMP nel rispetto delle procedure aziendali, degli standard di qualità e delle normative vigenti (leggi, norme GMP, FDA, etc.) e della sorveglianza delle attività produttive, diffondendo pro-attivamente la cultura qualità all'interno dei reparti.

Responsabilità
  • Effettua la revisione dei lotti GMP rilevanti e ne verifica la conformità alle specifiche, alle procedure aziendali ed alle normative vigenti dichiarandola mediante l'utilizzo dell'apposita check-list.
  • Effettua sorveglianze periodiche delle attività produttive e promuove la cultura qualità diffondendola pro-attivamente all'interno dei reparti.
  • Incoraggia la condivisione delle problematiche e delle relative azioni correttive con il reparto produzione mediante huddle periodici.
  • Partecipa, in collaborazione con il reparto produzione e il team PPI, al miglioramento continuo del reparto, fornendo supporto nell'implementazione di nuovi flussi, nell'ottimizzazione di procedure o nella creazione di tool PPI.
  • Esegue l'addestramento del personale coinvolto nell'attività di quality on the floor e di quello operante nei reparti per attività legate alla propria area di competenza, in accordo alle vigenti procedure aziendali.
  • Collabora con la funzione quality operations e con i quality specialist di reparto al fine di assicurare la corretta esecuzione delle indagini, fornendo supporto per la comprensione delle cause e partecipando all'identificazione delle più idonee azioni correttive o preventive, in accordo agli standard qualitativi aziendali ed alle normative vigenti.
  • Opera nel rispetto degli standard di qualità aziendali, attraverso l'applicazione delle procedure relative alla propria area di competenza, nel rispetto delle politiche e delle procedure di qualità aziendali ed in accordo alle normative vigenti (leggi, norme GMP, FDA, etc.).


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