Project Specialist

2 settimane fa


Roma, Lazio, Italia Takeda Pharmaceutical A tempo pieno

**RUOLO: Project Specialist**
**SEDE: Rieti**
**_ L'appartenenza alle Categorie Protette, ai sensi degli articoli 1 e 18 della legge 68 del '99, sarà considerata condizione preferenziale._**
**OBIETTIVI**
- Interfaccia operativa tra i fornitori/le strutture di raccolta e l'organizzazione Takeda BioLife per gli aspetti di Qualità e Logistica legati alla lavorazione del plasma italiano (Standard Operative Procedure - SOP, Supplier Notification of Change - SNC, Supplier Corrective Action Reports - SCAR, Look back e Post Donation Information, piano di ritiro plasma ed approvvigionamento del materiale di confezionamento)
- Supporto alle attività di Quality Assurance per l'inserimento e il mantenimento dei fornitori/strutture di raccolta nel Plasma Master File (PMF) aziendale: preparazione, esecuzione e follow up di audit (auditor e co-auditor), questionari annuali e dati epidemiologici.
- Preparazione della reportistica prevista da contratto attuativo relativamente al ciclo del plasma; partecipazione a progetti di ottimizzazione, continuous improvement e formazione.
- Supporto in campo per le attività IT con impatto sul sistema di Qualità (Validazioni dei sistemi gestionali, addestramento, procedure e standard tecnici richiesti per la spedizione del plasma, Dummy Shipments, progetti di miglioramento)
- Supporto al mantenimento dell'archivio documentale relativo alle attività di pertinenza, inclusa la responsabilità di prelevare e distruggere i documenti.
**Esperienza tecnico/funzionale**
- Esperienza in posizioni _Quality Relevant_ di almeno 2 anni
- Conoscenza dei principali sistemi e linee guida di qualità (gestione documentazione, sistema di audit, controllo dei cambiamenti, deviazioni, training)
- Conoscenza della normativa italiana ed europea in materia di plasma-derivazione
- Conoscenza ed applicazione del processo di valutazione dei rischi e delle normative ISO
**INFORMAZIONI AGGIUNTIVE**
- Buona conoscenza del pacchetto Office
- Ottima conoscenza scritta e parlata della lingua inglese
- Disponibilità a trasferte
**FORMAZIONE E COMPETENZE**:
- **Laurea tecnico-scientifica o titoli comparabili**:
**Locations**:
ITA - Rieti
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time



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