Ryan(Chaofu) D.

Experience

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  Schering plough

  Sept 2007 - Jan 2009

  QC Analyst

  Finish the test of in-process and finished product of API plant Finish the maintenance of equipment in QC Lab Calibrate the instrument of QC Lab Check the change of Standard Operation Procedure Sort out the columns of GC and HPLC

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  Boehringer-Ingelheim

  Jan 2009 - Sept 2010

  QC Analyst

  Finish the test of in-process and finished product Finish the test of package material Finish the test of API Finish the maintenance of equipment in QC Lab Familiar with USP ,EP ,ChP Check the change of Standard Operation Procedure Collate the column of GC and HPLC In charge of the sample and the COA distribution

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  United states pharmacopeia (usp)-China site

  Oct 2010 - Sept 2015

  Scientist II

  As Project leaderStandardize the USP reference materialPrepare/confirm the test capacity of USP reference material projectsInvolve the investigation of questionable sample with Market department. Prepare/review/approve the analyst report of USP reference material in Reference collaborative Lab Responsible for the establishment, execution of quality system in compliance with ISO9001 /ISO17025 Establish internal SOPs Handle OOSs and deviations with USP collaborative Lab, market department and USP HQOrganize and evaluate the technical training of new employeeDraft / execute the internal guideline for Custom goods management in Free Trade Zone. As Lab Operation SpecialistEquipment and sample database management, documentation management.As validation supervisor responsibility for all USP lab equipment including Calibration, Qualification, ValidationReceive/register/distribute the equipment and sample in Free Trade Zone, maintain the databaseResponsible for the Project of Lab Equipment Lifecycle Management.Responsible for the chemicals and consumables of LabLab management with EHS, including waste， reagent, hazardous chemical substance, PPE, etc.Prepare/review/approve the validation protocol and report, example for URS/IQ/OQ/PQHandle change control and deviations in regarding to qualification, validation and calibration processOrganize vendor validation execution and review and approval vendor’s validation protocols and reportsThe samples of Free trade Zone R&D custom system.Annual budget control of lab equipment.ISO 9001 internal Audit involved Show less

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  合全药业

  Sept 2015 - May 2016

  Quality Manager

  Lead Lab instrument groupAs validation supervisor responsibility for all lab equipment including Calibration, Qualification, ValidationInvolve to QC internal / external auditPrepare/review/approve the validation protocol and report, example for URS/IQ/OQ/PQHandle change control and deviations in regarding to qualification, validation and calibration processBudget control and make training plan

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  Henlius | 复宏汉霖

  May 2016 - May 2022

  QC Director

  Responsible for the management of QC department of Henlius YiShan Site (Total 110 staff)Responsible for the Data integrity and Lab informatic system in Henlius (Empower3, SDMS, ELN)Responsible for the tests (IPC & Release) and application material for the projects at different stageResponsible for the management of instrument (maintenance, re-qualification, calibration and etc.)Responsible for the budget and performance evaluation of departmentDeal with the audit from NMPA、EMAPrepare/review/approve SOPs, OOS/T and Deviation of Lab testingPrepare/review/approve validation protocol and reportFamiliar with the HPLC maintenance, repair and operation (Waters, Agilent, Shimadzu)Familiar with the analytical instrument validation and computerized system validationFamiliar with the analytical instrument such as HPLC , KF , IR , UV and etc.Involve the internal and external audits in Henlius. Show less

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  维昇药业

  May 2022 - now

  Director of Quality