Project Manager of Technology Transfer of analytical methods between Quality Control and R&D, and between Quality Control laboratories in Teva Global. Manage the HiH process with R&D to quality new products for testing in the QC laboratory including initial review of R&D methods, equipment procurement management, Review and approval of protocols, follow up on Technology transfer analysises in the Quality Control laboratory and write reports. Set and Manage timelines for transfer of Analytical methods.
Create analytical methods and analytical specifications for raw materials, in-process materials and finished products after completion of Technology transfers and in compliance with Pharmacopeias, updated supplier methods and review letters, as relevant according to approved change control procedure as well as coordinating the changes with Regulatory Affairs for assessment.
Where there is a request for alternative supplier for Post Marketing finished products, is responsible for supplying the professional analytical input, guidance and relevant handling.
Provides professional support to Regulatory Affairs in the preparation of submission files and review letters.
Method remediation – Update and revalidate commercial methods as required.
B.Sc. preferably in chemistry or other scientific field
M.Sc in scientific field - advantage
Experience working in laboratories (chemistry is preferred)
Training in cGMP.- advantage
Leading processes and project management abilities
Strong communication/interpersonal skills
High English level
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