Specialist in Sterile Pharmaceutical Production

4 settimane fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

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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