Found Description
Job Summary:
- Perform testing in IPC, finished products testing
- Familiar with HPLC & GC operations & troubleshooting
- Familiar with CE-SDS, cIEF, cell based potency, ELISA based qualification, Karl Fischer Titrator, Total Organic Carbon (TOC) testing, UV-Vis Spectrophotometer machines, FTIR.
- Manage laboratory supplies, conduct inventory, and place orders for replacements as needed.
- Follow established safety protocols and regulations to maintain a clean, safe, and organized work environment.
Other 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...