Training and Documentation Officer, Mrna

1 mese fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

**Work Schedule**

Other

**Environmental Conditions**

Office

Thermo Fisher Scientific Inc. è il leader mondiale nel servire la scienza, con un fatturato annuo di oltre 40 miliardi di dollari. La nostra missione è quella di consentire ai nostri clienti di rendere il mondo più sano, più pulito e più sicuro. Se i nostri clienti stanno accelerando la ricerca sulle scienze biologiche, risolvendo complesse sfide analitiche, aumentando l'efficienza nei loro laboratori, migliorando la salute dei pazienti attraverso la diagnostica o lo sviluppo e la produzione di terapie che cambiano la vita, noi siamo qui per supportarli. Il nostro team offre una straordinaria combinazione di tecnologie innovative, convenienza di acquisto e servizi farmaceutici attraverso i nostri marchi leader del settore, tra cui Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, e Patheon.

Thermo Fisher Scientific, cerca per la sua sede di Monza, in particolare per la Unit mRNA, un Training and Documentation Officer.

La risorsa entrerà a far parte del reparto produttivo dedicato alla manifattura di prodotti Drug Substance & Drug Product (clinici/commerciali) a base mRNA (mRNA Manufacturing Department) supportando il Team di Manufacturing attraverso: Training e Formazione del personale, stampa/preparazione della modulistica necessaria alle attività di produzione, revisione ed approvazione delle procedure e della documentazione compilata durante le attività di produzione e loro archiviazione.

In particolare, la risorsa si focalizzerà sulle seguenti attività:

- Creazione di corsi di Training, Training del personale e formalizzazione nei sistemi aziendali;
- Emissione di nuove procedure di uso o documentazione necessaria alle attività di produzione;
- Revisione e/o approvazione delle procedure in essere di stabilimento/reparto;
- Stampa e preparazione della modulistica/cartellonistica/etichette necessarie per la produzione di un lotto;
- Gestione delle copie controllate di reparto;
- Assemblaggio e revisione Batch Record di produzione;
- Gestione dell’archivio di reparto.
- Partecipazione alle riunioni della Business Unit

Requisiti
- Pregressa esperienza in reparti di produzione farmaceutica e della gestione della documentazione di reparto;
- Approfondita conoscenza delle cGMP, e gestione delle SOP di un reparto produttivo;
- Forti capacità comunicative e di coordinamento tra vari interlocutori;
- Conoscenza dell’italiano e preferibilmente buone basi di lingua inglese.

Unisciti a noi

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