Csv Specialist
1 mese fa
Per un'importante azienda operante nel settore delle biotecnologie, ricerchiamo un:
CSV Specialist
**Posizione**:
La figura ricercata dovrà:
- Occuparsi dei requisiti regolatori e degli standard di qualità richiesti dalle Autorità Regolatorie per gli aspetti di convalida dei sistemi computerizzati di stabilimento.
- Coordinare le attività di convalida dei sistemi computerizzati, lavorando congiuntamente al personale di: Conduzione e Gestione Impianti; Produzione; Controllo Qualità; IT e Farmacovigilanza.
- Effettuare il processo di gestione dei cambi dei sistemi computerizzati per valutare e assicurare il completamento delle necessarie attività di convalida.
- Supportare, anche operativamente, le attività di calibrazione strumenti, convalida/riconvalida equipment, utilities e processo produttivo.
- Approvare la documentazione pertinente la mansione (SOP, Working Instruction, ecc.) e garantirne il rispetto rigoroso.
**Requisiti**:
- Esperienza nel ruolo
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