More than 25 years quality control laboratory management experience.
Qualified ICH Q7A GMP auditor,ISO17025 auditor.
Team work spirit. High liability and Attribution。
Familiar with QC lab instrument.
Familiar with ISO 9001, 17025, cGMP and CMA quality system

Experience

  • National Quality Director & Lab Services SME

    at Sodexo China

    May 2016 - at Present

    Shanghai Shi

    Overseeing and the implementation of Sodexo’s Quality processes. Drive continuous innovation in Sodexo’s HSE operations delivery. Development and implementation “Best in Class” Facility Management related Quality reference standards. Be responsible for development and implementation of enterprise-wide “Best in Class” Laboratory Service reference standards Assess opportunities for lab services and lab program implementation and will maximize savings and opportunities for improving the lab efficiencies by leveraging economies of scale, best practices and innovations. Manage a team of Laboratory Services Compliance Managers to ensure professional and efficient support to Site Operational Teams. Provide support to Business Development and Transition activities

  • Head of HMC China Diagnostic Laboratory

    at Boerhinger Ingelheim China

    September 2014 - April 2016

    Shanghai Shi

    1 Integrated company internal and external laboratory resources for supporting the company's animal vaccine research and development, marketing and technical services 2 Draft HMC diagnostic laboratory investment plan, design laboratory layout, personnel recruitment and instrument purchasing 3 Coordinate the company's legal, financial, infrastructure, procurement and HR departments involve in the project, establish laboratory SOP system. 4 Be responsible for daily operation of lab, test equipment and consumable purchasing, personnel recruiting training

  • Senior Director of Analytical Department

    at Sundia MediTech Company,LTD

    January 2010 - September 2014

    Shanghai Shi

    1 Chemical support analytical laboratory management include chemical synthesis supporting, Processing Research supporting, GC laboratory, mid-scale LC preparation and NMR laboratory 2 Chiral laboratory management include Chiral LC method development and validation, Chiral LC preparation, SFC analysis and preparation. 3.cGMP compliance analytical laboratory and stability laboratory management.Project management of new drug development 4. Routine management of department operation, HSE, marketing promotion, Financial Management and draft investment proposal 5. Staff recruit, training and evaluation 6 Instrument purchasing approval 7. Setup and maintain cGMP quality system 1 Lead and finish several New Drug development projects include Class 1.1, 3.1 and ANDA 2. Setup and maintain cGMP quality system of laboratory and pass audit from several EU and US Big Pharm client 3. Purchasing and setup several NMR, SFC and LC-MS

  • Lab Director

    at Silliker China Biotechnological Science Co. Ltd

    January 2009 - January 2010

    Shanghai Shi

    1. Routine and R&D project management of laboratory 2. Routine management of lab operation, marketing promotion and staff recruitment 3. QA and HSE management improvement. Setup and maintain CMA and ISO 17025 quality system 4. Draft invest proposal of microbial lab and physical chemical lab. Instrument purchasing and qualification. 5. Responsible for sales and cost control, Finish several R&D project for new analytical method R&D such as pesticide residue test, antibiotic residue test etc. Purchasing and qualify LC/MS/MS. GC/MS, Titration, FTIR, Balance and UV etc. Acquisition of domestic lab and merge into group. Get ISO17025 CNAS and CMA accreditation

  • Department Manager

    at SGS-CSTC Standards Technical Services Co. Ltd

    September 2005 - January 2009

    Shanghai Shi

    1. R&D project management 2. Draft invest proposal of LSS microbial lab and physical chemical lab. Instrument purchasing and qualification. 3. Routine management of lab operation, HSE, marketing promotion and staff recruitment 4. QA and HSE management improvement. Setup and maintain CMA, ISO 17025 and cGMP quality system 5. Responsible for sales and cost control, Achievements: Set up and manage the first drug analysis lab of SGS group in mainland of China. It is also the first commercial third party drug analysis lab in China. Complete several R&D projects in new drug development, registration and analytical method R&D. Instrument purchasing and qualification Get ISO17025 and CMA accreditation in 2006 and pass the re-qualification in 2008 Reach the target of each year

  • QC Director

    at Shanghai Jiahwa Pharmaceuticals LTD

    October 2003 - September 2005

    Shanghai Shi

    New Drug R&D Project management include study, SFDA application delivery, registration. Lab management, instrument purchasing, recruit lab staff

  • Associate Director

    at Shanghai Pharmatech New Drug Development Co

    August 2002 - October 2003

    Shanghai Shi

    In charge of Built the Q.C.Lab, purchase instruments and invite employee. Have complete 4 applications for New Drug Application to SFDA.

  • Analytical Laboratory Technician

    at Henan drug control institute

    July 1992 - June 2002

    Henan Sheng

    Mainly worked for drug control and drug analysis.Also developed some kinds of new drug. Have worked for about 20 in all kinds of new drugs.

Education

  • Drug Analysis

    at China Pharmaceutical University

    1998 - 2002 (4 years) Jiangsu Sheng

  • Biotechnological

    at China Pharmaceutical University

    1988 - 1992 (4 years) Jiangsu Sheng

Languages

  • English Negotiation

  • Chinese Native

Hives