Quality System Specialist

4 settimane fa


Roma, Lazio, Italia Jefferson Wells A tempo pieno
Descrizione del Lavoro

Siamo alla ricerca di un Quality System Specialist esperto nel settore farmaceutico per lavorare con il nostro cliente importante.

Responsabilità Principali:

  • Definire la strategia e la direzione per il dipartimento Quality System, garantendo miglioramenti continui rispetto ai più recenti standard GMP nazionali ed internazionali.
  • Supportare e facilitare il miglioramento continuo del Sistema di Qualità, assicurando un aggiornamento tempestivo alle normative cGMP e agli standard internazionali Pharma e Nutra.
  • Garantire che la documentazione sia redatta e preparata in accordo alle linee guida GMP e agli standard del Sistema di Qualità aziendale.
  • Garantire che il personale sia correttamente formato sulle linee guida GMP e sulle procedure operative del reparto.
  • Garantire la corretta gestione e monitoraggio dei Change Control.
  • Assicurare la corretta preparazione della documentazione relativa a notifiche essenziali/non essenziali e la corretta sottomissione ad AIFA in accordo alla linea guida vigente.
  • Assicurare che i rapporti con i fornitori e con i clienti siano regolamentati da specifici accordi di qualità (Quality Technical Agreement).
  • Garantire che i fornitori siano qualificati secondo le linee guida aziendali e in accordo agli standard GMP.
  • Ispezioni da clienti e da parte di autorità: assicurare una completa inspection readiness, redigere il CAPA Plan e garantire il rispetto della chiusura delle attività on time.
  • Stabilire e monitorare gli obiettivi del reparto Quality System & GMP Compliance.
  • Monitorare e garantire il rispetto dei costi rispetto al budget per il proprio reparto.

Requisiti e Qualifiche:

  • Titolo di studio rilevante (Bachelor's/Master's degree) in un campo come Scienze Chimiche, Biotecnologie o Farmacia.
  • Minimo 5 anni di esperienza lavorativa nel settore farmaceutico, preferibilmente come Quality System Manager o GMP Compliance Manager.
  • Conoscenza approfondita delle normative GMP, ISO 13485 e delle relative linee guida.
  • Abilità nella gestione di team e nell'interazione con stakeholder.
  • Lingua italiana fluente.

Scheda Tecnica:

QualificaContestoNumeri e PercentualiTitolo di StudioScienze Chimiche/Biotecnologie/FarmaciaBachelor's/Master's degreeEsperienza LavorativaSettore FarmaceuticoMinimo 5 anniRequisiti Lingua Italiana"Italiano""Fluente"

Ricevimento Candidature:

Grazie per l'interesse. Risponderemo presto.



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