Specialist in Qualification of Equipment
4 settimane fa
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.
- 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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