Job responsibilities:
1. Be responsible for the literature review of the project;
2. Undertake the development and validation of analytical methods, and assist the preparation and synthesis departments in relevant experimental research;
3. Draft test plans, reports and other documents, tackle key and difficult technologies in the project, develop analytical methods, formulate quality standards, investigate the stability of drugs, timely solve various problems encountered in the process of quality research, and timely communicate with the superior for unsolvable problems to ensure that the problems are solved in time;
4. Grasp the details and degree of quality research, summarize and analyze all research materials and data to ensure the delivery quality of the project;
5. Timely complete the sorting of various test records, test data and research materials, and write the application materials for quality research;
6. Participate in the construction of internal management documents and processes according to the needs of standardized management of quality system to ensure the standardization and scientificity of department management.
Job requirements:
1. Bachelor degree or above, major in pharmacy, chemistry, traditional Chinese medicine, drug analysis, pharmaceutical preparations, etc., bachelor degree or above for more than 5 years / Master degree, more than 3 years of relevant working experience;
2. Independently undertake the quality research of at least one raw material and preparation project, data writing, consistency evaluation, project management, on-site verification, standard formulation, stability research, method development and verification, etc;
3. Have more comprehensive quality research experience: including the principle and use and maintenance of instruments and equipment, the principle and application of various analysis methods, policies, regulations and patented technology, literature review, understanding of GXP related documents, and understanding of relevant departments and industries;
4. Strong sense of responsibility, able to actively communicate with superior leaders and solve technical problems of subordinates in time.