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QC Documentation specialist

4 mesi fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Monza site is an outstanding pharmaceutical contract manufacturing and development facility, specialized in aseptic injectable drugs, with a growing focus on biologics. Joining more than 1800 colleagues on site, the selected candidate will experience an excellent, international, and fast-growing environment. With revenues exceeding $24 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create substantial contributions to the world.

Attuare le attività sotto riportate nel rispetto delle priorità definite dal Responsabile e degli standard di qualità aziendali.

Garantire la stesura e l’emissione dei metodi analitici per i raw material, prodotti finiti per il laboratorio chimico e dei relativi ATR (Analytical Test Record) in accordo alle farmacopee. Garantire l'emissione di protocolli e report di qualifica di test compendiali. garantire l'apertura e la gestione di change control interni. Supportare il team per la revisione, stesura e l’emissione delle specifiche necessarie a garantire la produzione. Garantire la redazione dei documenti di pertinenza in base alle necessità del team e alle priorità assegnate. Assicurare il completamento dei training assegnati entro i tempi previsti per garantire il corretto livello di formazione e l’aderenza alle procedure correnti. Garantire che tutte le attività svolte e tutti i dati emessi, vengano effettuati in conformità all’applicazione delle regole di Data integrity.

Requisiti:

Laurea in field scientifiche (CTF, Biologia, Biotecnologie..) Esperienza di almeno 1 anno in realtà farmaceutiche/biotech in ambito documentale e buona conoscenza delle GMP Buona conoscenza del pacchetto Office, buon uso del PC e dei sistemi informatici per la gestione della documentazione Buona conoscenza della lingua inglese Capacità di schematizzare processi/documenti Preferibile la conoscenza dei sistemi TrackWise e Documentum Preferibile conoscenza, anche di base, in ambito regolatorio (scrittura specifiche)

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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