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Pharmaceutical Analysis Researcher

1. Formulate and implement quality analysis related experiment plans based on technical guidelines of CDE and ICH and the department's guidelines and objectives to ensure that projects move forward smoothly per project timelines;
2. Conduct literature research for the project, compile materials related to quality standards and analytical methods, design the development and validation of analytical methods, and write the transfer plan and complete tech transfer of the quality analytical method;
3. Develop quality standards for products based on the quality of the products;
4. Write the CMC part of the application materials according to the requirements of CDE;
5. Responsible for the quality research part of filing and registration and on-site inspection of the project;
6. Proficient in using various analytical instruments required for the position, able to independently conduct experiments, compile and analyze data from experiments and timely complete original records and instrument usage records;
7. Familiar with the use and basic maintenance of common analytical instruments, and able to independently troubleshoot and solve simple faults;
8. Familiar with national laws and regulations and related guiding principles;
9. Participate in the management and training of the lab and assist in the establishment and improvement of the lab quality system;
10. Complete other tasks assigned by supervisor.