Regulatory Documentation Specialist

3 settimane fa


Monza, Lombardia, Italia Adecco Italia A tempo pieno
Descrizione del Lavoro

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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