Quality Assurance Specialist

3 settimane fa

Guidonia Montecelio, Italia Synthesis Srl A tempo pieno

La Risorsa riporterà al QA Manager e si occuperà principalmente di:
- Collabora alla gestione della documentazione del Sistema Qualità: redazione, verifica, aggiornamento, emissione, archiviazione di rapporti, protocolli, moduli, convalide, change, CAPA, deviazioni.
- Collabora alla raccolta dei dati necessari per la redazione ed aggiornamento del Quality Annual Report, in collaborazione con le funzioni coinvolte.
- Supporta nella stesura delle revisioni annuali di prodotto e dei trend analitici;
- Effettua verifiche di conformità della documentazione e delle registrazioni di sistema e di quelle relative ai prodotti.
- Partecipa agli audit da parte di Organismi Notificati / Enti di Certificazione / Clienti.
- Supporta nelle attività di approvazione e qualifica dei fornitori.
- Supporta nella gestione dei sistemi computerizzati;
- Definizione e supporto di piani e protocolli di validazione
- Verificare che processi aziendali macchine/Impianti siano sempre in stato di Qualificati in sinergia con le altre funzioni coinvolte e nel caso contrario provvede (piani e protocolli di validazione)
- Verifica che vengano eseguite le manutenzioni programmate nei tempi stabiliti dai calendari concordati.
- Assicurarsi che le necessarie calibrazioni siano eseguite secondo programma e che siano registrate
- Collabora con tutte le funzioni aziendali al fine di ottimizzare e condividere eventuali cambiamenti del Sistema Qualità.
Requisiti:
Titolo di studio: Laurea in discipline scientifiche (CTF, Farmacia o simili)
- Conoscenza delle GMP acquista mediante pregressa esperienza nei settori Assicurazione Qualità o Regolatorio di aziende farmaceutiche
- Esperienza nel ruolo di almeno 2 anni, in contesti produttivi;
- Ottima Padronanza pacchetto Office
Contratto di lavoro: Tempo pieno
Retribuzione: €1.700,00 al mese
Disponibilità:
- Dal lunedì al venerdì
Retribuzione supplementare:
- Straordinario
- Tredicesima
Sede di lavoro: Di persona

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