柱 李

Temporary job for new factory and lab design and building • New plant design, include process design, plant design, equipment selection and procurement. • Test lab and application lab design and equipment selection. • EIA task link to supplier. • Establish food safety system • Recipe design, include material selection • Food production license application business.

QUALITY & FOODSAFETY •Apply and ensure the compliance with Mars QMP standards, ISO9001 and ISO22001, GMP/GHP and 5S. •Coordinate HACCP team and support the department managers on food safety management and compliance with the standards. •Manage the Factory Lab for analysis in all the raw materials and final products. o Ensure the compliance of factory lab with RC Lab score requisites. •Responsible to train and audit daily activities of Lab technician on the analysis methods. Responsible to coordinate the communication with costumer claims to the Costumer Care department. •Manage the number of costumer claim and work on the action plan with related department Process, Flow, Packing or Maintenance. •Control all the documents and register related to the HACCP and QFS. •Responsible to schedule and lead internal audit of Food Safety, GMP and GHP. •Handle NC issues according to NC Policy. HUMAN RESOURCES •Evaluate and manage the training needs of the QFS team •Execute program of personnel development and specific skills training in relation with RC P&O concepts like multi-skills program

• Define the quality plan, including an internal and external quality audit plan, seek approval for it, implement, and manage the execution of this plan. • Monitor the execution of the quality plan and take corrective actions, in order to achieve the results. • Periodically review the quality systems and verify whether these are actual. • Define and implement performance indicators and ensure periodical reporting of actual performance against these indicators. • Ensure to have the appropriate systems (e.g. Quality Management System, cGMP) in place and maintained, in line with all applicable laws, regulations and standards. • Plan, execute and follow up on internal and external quality audits, in order to ensure that activities are carried out according to approved policies and procedures. • Ensure that the organization learns from deviations and that deficiencies found during internal and external audits are translated into corrective actions, monitor the execution of the corrective actions and escalate to the appropriate management level, if and where required. • Ensure site compliance with all applicable internal and external quality requirements, regulations and standards. • Provide final approval for releasing a product to market (or not) and raw material for manufacturing purposes. • Approve quality related documents (e.g. validation, deviations, complaints, audit reports and closeout reports). • Be the quality interface with customers and coordinate the complaint process. • Stay abreast of both internal and external developments with regard to quality related laws, regulations, requirements, and all other quality related matters. • Manage QC lab via QC supervisor

 RC&QMS business • Manage and mitigate significant quality & regulatory risks in GSK Suzhou through risk identification and full use of available risk management process. • Manage the RA business within GSK Suzhou. • Manage compliance training in Suzhou site. • Collect and analysis the regulatory requirement include GMP, GSP and other requirement. • Ensure site regulatory compliance to GSK & regulatory standards. • Ensure that all Suzhou site processes and systems meet high GMP and quality standards to comply with international, corporate and local requirement. • Ensure effective site QMS implementation process based on risk approach. • Ensure current QMS used in site. • Manage change control and CAPA system • Internal audit management  Additional responsibility for QA business: • Batch record review • Product release as the deputy qualified person • Raw material evaluation and release • Deviation, complaint and other issue investigation

 Product evaluation and release.  Deviation management includes CAPA.  Complaint handling and global complaint management system administration  Anti-counterfeit and quality issue.  Coordinating external audit.  Supplier audit  GMP training Achievements：  Product release timely according to marketing requirement.  Low deviation and complaint rate.  Complete all quality issue and anti-counterfeit smoothly.  cNo major non-conformance during external audit. Additional information about job rotation and promotion in AstraZeneca:  Sep. 2006- May 2008 coordinate all complaint and anti-counterfeit cases, include receiving, investigation, reporting and response to customer. Partly participate in the GSP audit.  June 2008 - July 2009 some sterile business have been add into the responsibility.  Aug. 2009 – Feb. 2011 QA business in the solid dose team, include change control, deviation, project risk assessment, supplier audit, batch record review, GMP training, and etc.,  March 2011 Promote to QA supervisor, handling the QA business involved in the packing business, participate the routine business discussion of trade company(GSP)