QC Scientist for testing
7 days ago
Job Summary
Experiences in raw material, IPC, environment monitoring, water testing, finished products testing and experience in HPLC & GC operations & troubleshooting, CE-SDS, cIEF, cell based potency, ELISA based qualification, Karl Fischer Titrator machines, Total Organic Carbon (TOC) testing, UV-Vis Spectrophotometer machines, FTIR machines, manual & auto-titration, bioburden, sterility, CCIT and endotoxin testing.
Requirements
A good understanding of the overall view of drug development process.
A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.
Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoieas.
Comprehensive knowledge in IND/IMPD, NDA and ANDA filing
English can be as working language.
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