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 )
1.Communicate with customer/partner and subcontractor to define the package design requirements, or specifications.
2.Propose the package size, structure according to requirements and specifications from customer.
3.Design the package and optimize to meet product specifications, coworking with related layout, electrical and thermal engineering teams.
4.Prototyping document preparation
5.Link with suppliers and follow up the development trend.
• 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