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Teva R&D CMC coordinator- Temporary Position Israel, Center District, Kfar Sava 903818334
07.07.2024
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Work within KS Generic R&D formulation development units.
Prepare sections/files/documents for projects to be submitted in US and support in updating documentation during deficiency letters form FDA.Work with different interfaces outside the Kfar Saba R&D: QC, packaging material lab, microbial lab.
How you’ll spend your day
- Prepare sections/files/documents for generic product submission for US market
- Update sections/files/documents as part of deficiency letters from FDA
- Prepare different protocols for submission for EU and CA markets
- Prepare API/excipients monographs and update monographs for all markets according to the R&D requirements.
- Work with SAP and LabWare systems
Your experience and qualifications
- Bachelor degree in the field of science (e.g., chemistry/chemistry engineering, biothechnology/biotechnology engineering)
- Chemistry/chemistry engineering – advantage
- Master's degree – advantage
Reports To
Dir R&D Department
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