Sunday, March 7, 2010

Prepare

1.Manage operation of Quality Assurance department and Analytical Research chi hair straightener 2.Review master batch record and master packaging batch record, review validation protocol and report and change control report 3.Review the test report of raw material and in-process product 4.Supply evaluation and approve qualified vendor 5.Prepare and revise chi straightener validation and cleaning validation protocol and report
1.Prepare and revise specification for R&D product and commercial product 2.Help chi straighteners to resolve OOS and other deviation 3.Prepare and review new drug application file 4.Prepare and revise method validation, cleaning validation and process validation protocol and report 5.Help QA to review master batch record 6.Participate in supplier audit

1.Study and synthesize new chemical entity and prepare new synthesis route 2.Optimize drug synthesis route for ondansetron and carvedilol and put into mass production in Tanwan 3.Prepare EDMF(ASMF) and DMF of carvedilol 4.Perform drug analysis by using HPLC,UV,GC and IR