Qc Documentation Officer

7 giorni fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
Thermo Fisher Scientific, World leader in Serving Science sta reperendo per la sua nuova Business Unit dedicata alla tecnologia mRNA un QC Biochem Analyst specialist.

La risorsa, all''interno del gruppo QC Biochemical laboratory, si occuperà principalmente di:

- Revisione delle procedure operative standard e relativa documentazione associata in Documentum
- Scrittura di Change control, Deviazioni, Indagini di laboratorio, OOS, SST failure tramite sistema Global TrackWise
- Scrittura ed emissione dei metodi analitici e degli Analytical Test Record per il laboratorio, interfacciandosi con il reparto Regulatory Affair
- Scrittura di protocolli e report analitici
- Apertura delle classi a sistema per il team tramite il sistema Success Factor
- Scrittura e revisione delle specifiche regolatorie per la parte Quality Control.
- Altre attività di supporto correlate secondo necessità

REQUISITI:

- Laurea in discipline scientifiche (CTF, Biologia, Biotecnologie..)
- Esperienza di almeno 1 anno in realtà farmaceutiche/biotech in ambito documentale
- Buona conoscenza del pacchetto Office, buon uso del PC e dei sistemi informatici per la gestione della documentazione, buona conoscenza di italiano ed inglese e capacità di schematizzare processi/documenti
- Preferibile la conoscenza dei sistemi TrackWise e Documentum
- Preferibile conoscenza, anche di base, in ambito regolatorio (scrittura specifiche)
- Soft skills: cerchiamo persone volenterose ed energiche, che verranno inserite in un nuovo progetto, molto stimolante. Fondamentali l'entusiasmo, la voglia di imparare e di mettersi in gioco

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