Manufacturing Sterile Operator

2 giorni fa


Ferentino, Italia Thermo Fisher Scientific A tempo pieno

Provvede ad operare sulle macchine di produzione seguendo le indicazioni descritte sul Batch Record e sulle SOP vigenti

Compila il Batch Record e la documentazione di reparto relativa alle mansioni svolte, li controlla,eseguendo i calcoli della riconciliazione come definito da procedura

Effettua le operazioni di pesatura dei principi attivi ed eccipienti in accordo al batch
- Record ed alle SOP in vigore in relazione all’area interessata.

Prepara le soluzioni destinate a riempimento in accordo al Batch Record ed alle SOP in vigore

Esegue i controlli ambientali in accordo al Batch Record ed alle SOP in vigore

Provvede a caricare all’esterno dello Sterile le linee di riempimento verificando la conformità dei materiali con quanto previsto dal Batch Record

Effettua il test d’integrità dei filtri seguendo le indicazioni descritte sul Batch Record e sulle SOP vigenti

Utilizza l’autoclave per la sterilizzazione terminale dei prodotti seguendo le indicazioni descritte sul Batch Record e sulle SOP vigenti (reparto sterile 3)

Effettua la pulizia delle macchine di produzione alla fine delle attività di produzione seguendo le indicazioni descritte sul Batch Record e sulle SOP vigenti

Provvede alla pulizia dell’area di lavoro alla fine delle attività di Produzione in conformità alle SOP vigenti

Provvede ad effettuare una verifica giornaliera al fine di assicurare la costante disponibilità dei materiali per la gestione dell’area di lavoro

Effettua il cambio formato.



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