Beschreibung
Associate Document Manager GMP/Pharma
Aufgaben
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Als Dokumentationsspezialist für unsere Herstelldokumentation erstellen Sie elektronische Master Batch Records in unserem Manufacturing Executions System (PAS-X) als Grundlage für die Herstellung.
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Nach erfolgter Herstellung prüfen Sie die ausgefüllten elektronischen Dokumente sowie allfällige Beilagen (Papier).
Fachliche Kompetenzen
- Erfahrung in GMP und Herstellung von festen Arzneimitteln ist wichtig. Es handelt sich um eine qualitätsbezogene Rolle.
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Grundlegende Kenntnisse der Herstellung von festen Arzneiformen, Erfahrung im GMP-Umfeld sowie Interesse an einer komplexen Software von Vorteil.
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Im Pilotbetrieb für feste Arztneiformen werden technische Chargen zur Formulierungsentwicklung sowie klinische Muster für Phase 1 und 2 Studien unter Berücksichtigung der Regeln der guten Herstellungspraxis (GMP) hergestellt.
Sprachen
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Deutsch in Wort und Schrift, Englischkenntnisse von Vorteil
To learn more about this opportunity please send your CV ASAP in Word format to Brine SA.
Work location: Basel
Start: ASAP
Duration: Until Aug 2018
Workload: 100%
Salary: Local Market rate according to experience
Permit: EU permits
Ref. Nr.: HS2267
BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:
Financial services sector, especially banks and insurance companies
Pharmaceutical industry
Government and services sectors
BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.
IT - Resources
We offer our top consultants, computer Profi's and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions. BRINE SA is especially distinguished by its renowned characteristic strengths:
Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.
Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA
Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.
BRINE SA is ISO 9001:2008 certified since 2014