1. Process review
2. Process development & optimization
3. Scale up
4. Technology transfer to production
5. Impurity profile establishment
6. Reference standard preparation
7. Product specification establishment
8. Project evaluation and management
9. trouble-shooting
10. relevant documentation (SOP document, derivation, OOS, DMF filling )
• Perform assigned QC work, including routine and non- routine, independently The non-routine work may include method transfer/verificati on/ validation , protocol driven study, or investigations.
• Trouble-shooting capability for QC technologies .
• Assist in reviewing QC documents including notebooks, datasheets, experimental records, and logbooks
• Provide guidance to specialists and lab technicians as assigned
• Check the preparations of reagent, volumetric solutions, and test solutions
• Perform method verification/ quali ficati on/ validation as required .
• Assist in preparing SOP, protocol trai ning, and assigned analytical works