Specialist in Sterile Pharmaceutical Production
4 settimane fa
Il nostro stabilimento produttivo di Monza è un centro di eccellenza globale per la produzione di farmaci sterili conto terzi. Sarai parte di un team di 2000 colleghi in un ambiente giovane, dinamico e fortemente orientato all'obiettivo. Con un fatturato di oltre 40 miliardi di dollari e i più grandi investimenti in R&D del settore, Thermo Fisher Scientific fornisce alle persone le risorse e le opportunità per contribuire in maniera significativa al raggiungimento del nostro obiettivo: aiutare i nostri clienti a rendere il mondo un luogo più sano, pulito e sicuro.
SCOPO DELLA POSIZIONE/RESPONSABILITÀ:
Sarai parte dell'unità dedicata alla produzione di farmaci iniettabili sterili, nella Business Unit DPS.
Affiancherai direttamente il Supervisor e Team Leader/Lead per assicurare la corretta compilazione di tutta la documentazione prodotta durante lo svolgimento delle attività produttive di reparto, in ottemperanza a quanto previsto dalle norme GMP e dalle procedure in vigore.
In particolare, ti focalizzerai sulle seguenti attività:
- Assemblaggio e revisione Batch Record di produzione
- Stampa (attraverso Printing tool) e archiviazione allegati
- Supporto alle attività documentali di reparto
- Utilizzo di Paletti per la corretta gestione dei materiali utilizzati durante le lavorazioni
- Utilizzo di Documentum per lettura delle SOP di reparto e di sito
- Utilizzo di SFF per gestione training e retraining
- Garantire il rispetto dei KPI di reparto
REQUISITI
- Laurea in CTF, biotecnologie o similari (non obbligatoria)
- Pregressa esperienza in reparti dedicati alla produzione farmaceutica e della gestione della documentazione di reparto
- Approfondita conoscenza delle cGMP, e gestione delle SOP di un reparto produttivo
- Forti capacità comunicative
- Conoscenza dell'italiano
- Capacità di utilizzo dei principali sistemi informatici
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