1、Development, validation and confirmation of methods for the determination of raw and auxiliary materials and packaging materials, as well as the testing and release of related samples.
2、Comprehensive analysis of raw and auxiliary materials and packages, including conventional chemistry and purity and impurity testing through internal development and/or pharmacopeial testing methods, identification testing, and other related quantitative analysis, physical and chemical testing.
3、Complete the sampling of each test sample and inspection of raw and auxiliary material inspection items on time in accordance with SOP.
4、Participate in managing the procurement, verification, calibration, and maintenance of relevant raw and auxiliary materials and packaging materials measuring instruments to ensure that the instruments can work stably and normally.
5、Manage relevant measurement data, ensure the accuracy, integrity and validity of product and sample measurement data, and be responsible for managing relevant measurement records and reports.
6、Participate in the training and guidance of technical staff.
7、Ensure that the routinely scheduled sample testing is performed within the specified turnaround time.
1、Bachelor degree or above in pharmaceutical analysis, biochemistry, biopharmaceuticals and other related majors.
2、Knowledge and/or familiarity with the Chinese Pharmacopoeia raw and auxiliary materials, package materials related test methods.
3、Familiar with relevant determination methods, such as Chinese Pharmacopoeia limit check method, pH determination, osmolality, infrared spectroscopy, Raman spectroscopy, TOC, conductivity, etc.; familiar with the use of relevant analytical instruments is preferred, such as HPLC, GC, TLC, infrared spectroscopy, Karl Fisher, etc.
4、Familiar with GMP and related pharmacological regulations, can comply with sample analysis, data management and report writing.
5、Serious and meticulous, efficient and logical, with a strong willingness to learn, responsible and team-oriented, good communication skills, execution ability and organization and coordination ability.