1.Responsibility：Assist GM to manage medical device system.※Organize to establish and implement production&quality system for new medical device project. ※Organize training.※Draft plan and implement internal audit.※Approve system documentation and product release.※Organize management review and output the review report, and ensure constant improvement of the medical device system.※Report to the GM on general management overview and major issues that may affect the safety and effectiveness of medical device. Assist GM to develop measures and take actions for risk control, if necessary, actively report to local authorities of NMPA.※Arrange general affairs for official inspection and finish remediation for all found defects.2.Report to: GM Subordinates：50 members3.Achievement※Organized to newly complete medical device system.※Organized to finish product developing&design and process validation, made remediation actions for all defects and successfully passed the on-site inspection for the new product registrations.

1.Responsibility：To manage general affairs of quality system in Quality department.※Internal and external audit. ※Documentation system.※Training and vendor management.※Implement ongoing process verification, annual quality review.※Disposal of complaint from customers, return and exchange of sold products, and ADR incident.※Organize quality management review and establishment of medical device system.2.Report to: Quality Director Subordinates：10 members3.AchievementThrough all-round and various types of exclusive internal audit, the company successfully passed more than 10 times of inspections, including all the official inspections by EU, PIC/S, FMHACA(Ethiopia) and CFDA, the on-site inspection for registration of some new drugs, and several customer’s audits. All the remediation reports in response to official audit have been completed.

1.Responsibility：To manage and push forward the analytical affairs of 2 new projects.※Preparative work of GMP QC lab establishment. ※Instrument validation.※Trail test for new project.※Quality system establishment of QC.2.Report to: Quality VP of Headquarter, GM 3.Achievement※Completed basic management procedure and test procedure draft for new QMS.※Solved stubborn problem about method reproducibility, optimized part of them for one project.※Finished type selection through supplier screening for analysis instruments and equipment for QC lab, drafted relative URSs and finished approval.

1.Responsibility: To be responsible for API production related work in GMP QC lab※Establishment and maintenance of Quality system for QC※Management of analysis work related to API production ※Sampling and GMP release testing for RM, FI, FP, and reference standards. ※Analytical method validations ※Stability study※Analytical method development and validation for cleaning process※Routine lab management※Management of instrument/equipment, reference standards, reagents, retained samples, labels and documents.※Arranged training for new employees ※Deviation/OOS investigation and resolution※Instrument validation and qulification ※Annual products review ※Periodical achievement evaluation2.Report to: Vice-general Manager of R & D 3.Achievement※Led QC team to finish quality system establishment for QC dept. ※Improved data integrity of QC lab to meet requirement of FDA21 CFR Part11. ※Led GMP QC lab to successfully pass official inspection by Health Canada in Nov. 2016.

1.Responsibility: To be in charge of AR&D work of API projects※Analytical method establishment, method validation and procedure draft for RD projects. ※PSS testing for supplier screening※Release test of Reference Standard for RD projects※Method development for impurities of RD projects and purification of impurities by pre-HPLC.※Routine management in ARD Lab 2.Report to: Senior R&D Manager 3.Achievement※Effectively promoted API projects to finished method establishment and validation for 2 API projects and part of 3 new API projects.※Wrote up related analytical files and transferred to headquarter of APOTEX group in Toronto.