徐晶莹 Email & Phone Number

Shanghai

1.Support independently in analytical field for the preparation and purification of API or intermediate compound. Two or three projects can be supported at the same time.Analytical support includes method development,method prevalidation, basic tests and product release. Method development and prevalidation include the followings,(1) method development and prevalidation for identification, IPC, assay and impurity determination of some compound.(2) Method development and prevalidation for residual determination of PGI in some compound.(3) Method development and prevalidation for Residual solvent determination in some compound.(4) Method development and prevalidation for chiral compound.Basic tests include assay, purity, water content by KF, impurity or chemical identification by GC-MS or LC-MS, optical rotation, titration and so on.2.Routine tasks include the following parts, (1) Method development and prevalidation using HPLC, GC, LC-MS, GC-MS and so on, (2) product release, (3) working standard characterization, (3) PM and PQ, (4) analytical support for IPC sample, (5) Assist the group leader conducting 5s management and (6) Method, CoA, Spec writing and transfer.3. Give techinical guide to Junior chemists. 4. Make stability study of some compound based on clients' requirement. 5. Instruments used in the method development include but not limited to GC-FID, GC-ECD, GC-MS, headspace GC, UPLC, LC-MS,LC-MS-MS, LC-ELSD, LC-DAD, LC-CAD, KF titrator, OR, TGA, DSC and so on.

Wuxi

1.Take personnel rotation in manufacturing, R&D and quality department for about one year. Having a knowledge of the manufacturing process under GMP, the development of a product, the standard operation procedures of the product and quality-related documents.2.In charge of the quality audit recording from foreign company such as Novartis and AZ.3.In charge of the Equipment Qualification, Method Validaiton, SOPs, User Records and Maintenance for all the precision instruments in labs, including UV-Vis, TOC, FT-IR, DSC, AAS, TG, Turbidimeter and so on. Methods are developed and validated such as Rapid detection of total ash of stoppers by TG, evaluation of washing detergent residue on stoppers by UV-Vis spectrometer.4.In charge of some cooperative projects with Institute of Chemistry, Chinese Academy of Sciences(ICCAS) and Beijing Research and Design Institute of rubber industry(BRDI). ICP-MS, GPC, XRF, Pyr-GC-MS, HPLC are used in these cooperative projects.Related projects include the analysis of the formulation component of the rubber stopper, the safety evaluation for the FEP film and so on.5.In charge of the translation of some process control documents, QMS documents and part of USP, CP and EP.6.Support the quality department to solve some quality complaints using different detection methods. Besides, give training to QC about the operation of the precision instrument.7. Assist the manager to purchase the precision instruments and make pre-investigation.

Master'S Degree, 化学

Bachelor'S Degree, Chemistry

Activities and Societies: 科协