Manufacturing Sterile Operator
2 giorni fa
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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