Operating duty
1) Assist in the research and evaluation of the equipment required by the analysis laboratory, and establish and improve the SOP< br />
2) Responsible for retrieving the domestic and foreign quality standards, test methods, reference materials and other information of listed drugs, and evaluating the feasibility of the project< br />
3) Support the preliminary research and development of Class 2 innovative drugs (chemical drugs) in the preparation department, including but not limited to method development, method validation and sample detection< br />
4) According to the company's objectives, draw up the analysis and research project plan, be responsible for the CRO test plan review, quality standard formulation, review and analysis of test data records, follow up the progress of outsourcing projects, coordinate and communicate to ensure the implementation of the research plan< br />
5) Support the transfer of analysis methods, and write or review the analysis and application data in CTD.
Qualifications
1) Major in drug analysis, with a master's degree of more than 3 years or a bachelor's degree of more than 5 years of analysis and development experience< br />
2) Familiar with domestic and foreign registration regulations and relevant guiding principles, such as ICH, domestic and foreign pharmacopoeia< br />
3) At least one year's experience in the development of topical preparations or Class 2 innovative drugs is preferred< br />
4) The person in charge of leading or undertaking the analysis of domestic and foreign drug declaration, and the person who has been inspected by the regulatory authority is preferred< br />
5) Be familiar with the writing of CTD analysis application data< br />