Regulatory Documentation Specialist
3 settimane fa
Il candidato selezionato sarà responsabile della gestione delle specifiche normative per i farmaci e dei progetti assegnati. Collaborerà con tutte le funzioni interne all'azienda per la realizzazione di specifiche analitiche nel rispetto degli standard qualitativi aziendali.
Compiti Principali
- Riportare al Supervisore PDS AD&GMP per garantire il proseguimento con successo dei progetti all'interno del PDS.
- Collaborare con le funzioni interne per la realizzazione di specifiche analitiche.
- Responsabile delle specifiche regolatorie per API, Eccipienti e DP.
- Collaborare con i Clienti, QC PDS e Regulatory Department per emettere le specifiche corrette per i progetti PDS.
- Fornire consulenza normativa e strategica a clienti interni ed esterni.
- Pianificare le attività future dei clienti e sollecitare altri progetti in linea con gli obiettivi dell'azienda.
Requisiti e Qualifiche
- Laurea in ingegneria chimica, chimica o esperienza lavorativa equivalente presso aziende farmaceutiche.
- Ottima conoscenza delle normative farmaceutiche.
- Capacità di lavoro indipendente e autonomo.
Benefit
Mensa aziendale e benefit previsti.
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