Xuhui District, Shanghai, China
More than 20 years working experience in the pharmaceutical industry, have many years of quality management experience in the top multinational enterprises in the world (such as Novartis, Baxter, Boehringer Ingelheim). Familiar with the production process and quality control of API, non-sterile and sterile preparation, Chinese patent medicine, etc. Have experience in quality management of international product transfer project, and experience in commercial quality management. Familiar with domestic and foreign pharmaceutical related regulations (GMP、GSP、GLP、GDP, etc.) and have plenty GMP certification experience. Organized many times domestic GMP certification of API, sterile and non-sterile preparation and passed. Organized TGA international GMP certification and passed with no critical and major observation. Organized the third-party mock audit for EU and FDA certification and passed. Have sufficient experience in quality management such as On-site quality control, deviation, CAPA、 change, complaint, document management, product release, PQR/ADR, supplier management, external audit, self-inspection, QC management, re-registration management and supply chain quality management, etc. Familiar with SAP、TrackWise、LIMS systems. Experience in API registration in FDA and Europe. Experience in quality research of product development. I have pharmaceutical professional background, rich quality management experience in pharmaceutical manufacturing, outstanding professional ability and business achievements. Good oral and written language skills (German and English), I hope individuals and enterprises can develop together.
负责MAH公司质量运营管理，包括研发、生产、经销过程中质量管理。
Description: 1. Be responsible for the quality management of overseas product technology transfer project. 2. Be responsible for the quality management related GXP of overseas CMO factory. 3. Be responsible for overseas supplier management. 4. Evaluate the APR/PQR report and stability report of the product, and perform trend analysis. 5. Be responsible for GSP related commercial quality management, include but not limited review quality complaint report, write and sign QAA with distributor, perform audit and issue audit report, translate COA/COC and provide to customers. 6. Sign quality agreements with overseas manufacturers, agents and distributors. 7. Perform quality audit to overseas manufacturers, suppliers and distributors and issue audit report. 8. Responsible for supporting product registration, and reviewing the submitted dossier for registration in different countries. Where applicable, review contents for accuracy when Chinese versions are required. 9. Be responsible for efficient technical complaint management. Lead meetings with manufacturing sites on quality complaints and review the investigation report. Follow up on CAPAs identification and implementation. 10. Evaluate the transport temperature of imported products, and issue the risk assessment reports to release the products to market. 11. Respond to and address quality-related issues raised by customers and assist to handle the quality related issue raised in supply chain. Achievements: 1. Established market release process and complaint handling SOP for international products ; 2. Drafted and signed two QAAs of contract manufacturing with FP manufacturers and one Supply QAA with API suppliers. 3. Drafted and signed 13 QAAs with international and domestic distributors. 4. Completed the market release of more than 40 batches of imported products and issued the translated COAs in Chinese.
Description: 1. Be responsible for the quality management of overseas product technology transfer project. 2. Be responsible for the quality management related GXP of overseas CMO factory. 3. Evaluate the APR/PQR report and stability report of the product, and perform trend analysis. 4. Sign quality agreements with overseas manufacturers, agents and distributors. 5. Perform quality audit to overseas manufacturers, suppliers and distributors and issue audit report. 6. Responsible for supporting product registration, and reviewing the submitted dossier for registration in different countries. Where applicable, review contents for accuracy when Chinese versions are required. 7. Be responsible for the quality system management of subsidiaries of the group. 8. Set of annual quality KPI of the group, regularly convening QMR and conduct annual internal self-inspection. Leaving Reason: Corporate internal organizational restructuring Achievements: 1. Performed the GMP on-site audit for a contract lab, a sterile product plant and a nasal spray plant in Europe within two weeks; 2. Performed the GMP on-site audit for an API plant and a sterile product plant in Europe within one week; 3. Completed annual internal self-inspection to two domestic pharmaceutical factories; 4. Reviewed the QAA of product transfer and the PQR, and identified issues that need to be paid attention to in the QAA and PQR report to avoid quality risk. 5. Reviewed and approved the analytical method transfer validation protocol and report, process validation protocol and report, stability test plan and report as planned. 6. Wrote and issued product testing specification. 7. Organized regular meeting to follow up the product technology transfer project, and handled quality related work in project in time to ensure the project completed on time. 8. Drafted and signed of several quality agreements related to domestic distribution.
1. Organized and coordinated two domestic GMP certifications, one domestic GMP unannounced inspection, one internal audit by BI group, one Australian TGA audit and one mock audit before FDA inspection as planned and successfully passed. 2. In the company's innovation and improvement program, I completed the optimization of the registration and QA workflow. And then, it was the first time in our company that completed the registration inspection of new products and supplied the market within 3 months. 3. Organized the annual review of all suppliers according to the plan. 4. Organized and completed three times of self-inspection from 2015 to 2017, and made self-inspection plan from 2016 to 2018 and the training plan for the inspector. 5. Took the initiative to optimize the self-inspection process and improve the identification efficiency of observations. 6. Organized the expansion of self-inspection team and improved the quality management level of self-inspectors in various departments through training. 7. Optimize the change control process as the plan, and the completion rate of change on time reached 100%.
Description: 1. Validate and maintain the database of batch release system to ensure the accurate release of the product. 2. Review and sign batch record to ensure that all operations of the production complied with GMP and SOP requirements, and report any identified issue to the management team. Present issues and lead discussions related to Quality with technical person as required. 3. Establish good relations with other operation departments and work together to maintain the batch release system. 4 Perform monthly summary batch release data and trend analysis to support quality review. 5 Manage and ensure timeliness of quality related documentation to be provided to product release. Quality related documentation include but is not limited to BPR, testing record, validation report, deviation report, change record, etc. 6 Ensure on time and accurate batch release system. 7 Ensure efficiency of document management system. 8 other tasks assigned by the Manager. Leaving Reason: Career development planning, shift to GMP management of quality systems and audit compliance Achievements: 1. Completed the optimization of batch release process as planned, and saved 15% of the batch release time than before. 2. Leaded the evaluation of computer system validation for batch release system as planned and finalized the URS and system design. 3. Optimized the process of QMR and conference procedure, and improved the effectiveness of QMR, so that the questions raised in the meeting will be resolved before the next meeting. 4. Optimized the procedure of APR/PQR, and improved the effectiveness of APR/PQR. Completed the APR/PQR as planned with no delay.