Job duties
1. Be responsible for quality study of chemicals (bulk pharmaceutical chemicals and preparations) and product evaluation, solve technical matters encountered during study, formulate rational project research plan, and actively track and promote project progress.
2.Take charge of specific experimental operations related to quality study.
3. Take charge of training of laboratory technicians and technology transfer personnel and inspection operation instruction.
4. Be responsible for filling drug declaration materials;
5. Participate in laboratory management and plant maintenance, promote and improve the building of relevant system of the department.
Qualification
1.Education background: full-time university bachelor or above
2. Field of study: Pharmaceutical analysis, analytical chemistry, and the like
3. Work experience and competency:
1） More than 3 years (master degree or above) or 5 years (bachelor degree) of experience of research and development of chemical raw materials and preparations, and held the position of the person chiefly in charge of projects during research and development, have successfully completed clinical application or declared production of multiple varieties, and independently prepared declaration materials.
2） Know well about pharmaceutical manufacturing links from development to production, technical requirements, procedure of submission for approval, and pharmaceutical laws and regulations.
3） Competent for the position of project leader of drug quality study, including formulating comprehensive research and development plan, making overall arrangement of personnel and equipment rationally, and guaranteeing R&D efficiency and finishing quality.
4） Proficient in use and routine maintenance of common analytical apparatuses.
5）Master drug test operations, and be capable of troubleshooting analysis tests.
6）Familiar with information retrieval on related domestic and foreign websites.
7）Good command on English, and good communication skills and writing ability.
4. Have good professional ethics, strong ability to organize and coordinate and team management ability, positive attitude towards work, and initiative.
5.Preference will be given to the one with experience of quality evaluation of external preparations or proficiency in applying liquid chromatogram-mass spectrography technology.
