Specialist in Qualification of Equipment

4 settimane fa


Roma, Lazio, Italia Catalent A tempo pieno
Catalent: Leader in Drug Development and Delivery

Catalent è un'azienda leader nel settore della sperimentazione clinica e della produzione di farmaci. Stiamo cercando un Specialista in Qualifica degli Equipaggiamenti per unirsi al nostro team.

Responsabilità principali:
  • Eseguire le attività di qualifica degli equipaggiamenti e delle utilities per garantire un'elevata qualità della produzione;
  • Revisione della documentazione tecnica descrittiva di sistemi, equipaggiamenti ed utilities da qualificare;
  • Definizione della strategia di qualifica mediante scrittura di Risk assessment;
  • Sviluppo/revisione della documentazione tecnica di qualifica e di tutti i documenti a supporto della qualifica;
  • Supporto al mantenimento dello stato di qualifica dei sistemi, equipaggiamenti ed utilities;
  • Interfaccia con fornitori e clienti;
  • Lavoro in team in progetti CAPEX e in altri team interfunzionali;
  • Partecipazione attiva a Audit di Enti Regolatori e Clienti;
  • Mantenimento dello stato di aggiornamento del corpo procedurale afferente al gruppo dell'Equipment Qualification.
Requisiti:
  • Preferibilmente tre anni di esperienza pregressa nel ruolo;
  • Laurea in Chimica, CTF, Biologia, Biotecnologie, Ingegneria Chimica;
  • Buona conoscenza e padronanza della lingua inglese, livello B2 minimo sia scritto che parlato;
  • Conoscenze statistiche e delle logiche dei principali sistemi applicativi e gestionali;
  • Capacità comunicativa, di ascolto e di mediazione.

Catalent offre opportunità di carriera ricche e stimolanti. Unisciti al nostro team e aiutaci a portare oltre 7.000 prodotti farmaceutici a pazienti in tutto il mondo.


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