1.Manage operation of Quality Assurance department and Analytical Research Department 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 chi pink dazzle in-process product 4.Supply evaluation and approve qualified vendor 5.Prepare and revise chi hair straightener method validation and cleaning validation protocol and report.
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1.Prepare and revise specification for ralph lauren polo shirts product and commercial product 2.Help QC 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.Establish Lacoste Polo Shirts and strengthen software for six GMP systems from 2006 Update hardware system and perform validation from 2006. Adjust performance of HVAC system and perform validation for Cheap Lacoste Polo Shirts and HEPA filter system. Perform PQ for purified water system in accordance with USP. Perform temperature and humidity mapping validation for warehouse. Update and validate the hardware system of all lab equipments so as to meet the requirement of part 11,21CFR. Perform the transportation validation to make sure transportation from china to USA will not affect the quality of the product.Review DMF of API factory and audit the API factory several times in 2006, 2007 and 2008 so as to make sure all system meet the requirement of cGMP. Participate in FDA’s inspection to this API factory in September of 2008 and help API factory to make response to FDA’s Form 483 and follow its CAPA. Produce acyclovir tablet in January of 2007and perform stability test, submit the ANDA market authorization application to FDA in December of 2007. Perform continuous cGMP training to all staff, including regulation of ICH, PIS/S, chi hair straightener GMP and WHO GMP. Perform cleaning validation and process validation to all products which share equipments with acyclovir tablet Received Pre-approval inspection by FDA from February 23 to February 26 of 2009 and passed the site inspection and get the EIR in May of 2009.
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