Overall Summary
- Provide the strategic and technical leadership for the development and maintenance of the quality systems and the quality organization, to ensure that operations can meet GMP requirements and the requirements of the company quality policy.
- Monitor effectiveness of quality systems, including performance of self-inspections, quality metrics monitoring and participation in management reviews.
- Lead development & implementation of the data integrity governance plan according to health authority requirements and industry practice. Lead and work cross-functionally to understand, prioritize and mitigate data integrity risks.
- Seek continuous improvements of productivity, working environment and awareness of responsibility within Quality Department.
- Implementation of systems to ensure GMP-compliant engineering and compliance activities in support of site operations and capital projects. Assignments include oversight of capital projects, critical facility systems and equipment to ensure that they are designed, built, installed and qualified are compliant with Good Manufacturing Practices regulations.
Work Experience
| 2017/05 – Now： | Hong Kong Brighter Future Pharmaceutical Limited | Group Management 2017/5 – 2018/1: Working as Knowledge Management Manager, responsible for the development, improvement and implementation of the corporate group engineering knowledge management with LEAN system management, Engineering document lifecycle management, commissioning & qualification system. 2018/1 – Now: Working as Compliance Manager, responsible for the development, improvement and implementation of the corporate group quality management system with PIC/S 14 GMP implementation, supplier management, training management, data integrity, e-QMS, regulatory updates, quality culture. |
2007/07 – 2017/03: |
Beijing Novartis Pharmaceutical Plant | QA/QC | Quality Management 2007/3 – 2007/7: Working as EPCP1 project document administrator, responsible for project document lifecycle management. 2007/7 – 2011/3: Working as QC lab specialist, responsible for QC lab capital management, utility/equipment purchasing, qualification, calibration, maintenance and supporting of people management. 2011/3 – 2013/10: Working as senior QA compliance pharmacist, responsible for regulatory compliance, change management, deviation handling, facility/equipment qualification, external/internal inspection and audit and gap analysis/implement for global guideline. 2013/10 – 2016/09: Working as QA compliance team lead, assurance of local concept/guidelines for quality management system, including computerized system validation, e-compliance, change control and equipment/utility qualification are aligned with cGMP and Novartis requirements. Champion and promote importance of data integrity at the site. 2016/09 – 2017/03: Working as compliance manager, responsibility to provide the strategic and technical leadership for the development and maintenance of the quality systems and the quality organization at the site and to ensure that validation and operations of the facility meet GMP requirements and the requirements of the Novartis Quality Manual. Champion and promote importance of data integrity at the site. As qualified data integrity trainer, deliver DI Advanced Training and DI Learning Map to Novartis sites in Asia regional. |
Project Experience
2016/09 – 2017/03: ONE CSV Project
Responsibility: Site ONE CSV Program Lead
Project Description: As site ONE CSV Program lead, deliver ONE standardized and efficient CSV framework, this will cover the full life cycle of an application, from initial validation until final retirement, to reduce and more consistent validation efforts, more efficient life cycle management through common processes & tools and enhance compliance levels.
2015/08 – 2017/03: Data Integrity Project
Responsibility: Data Integrity Champion
Project Description: As data integrity champion, lead development & implementation of the data integrity plan according to global / divisional data integrity plan. Lead and work cross-functionally to understand, prioritize and mitigate data integrity risks. Leader of data integrity education and communication module in Novartis Asia cluster. Novartis certified data integrity trainer in Asia cluster.
2015/09 – 2016/5: DocStore-VIPER Project
Responsibility: Project Team Lead
Project Description: As project team lead, overall the project management coordinates with cross function departments, establish the project schedule with global management team.
2012/01 – 2015/06: Asset Change Control
Responsibility: Project Team Lead/Project QA
Project Description: As Project team lead, responsible for communication with global project team, do the gap analysis, and establish the local implementation strategy.
2009/05 – 2013/06: Site Extension Project Phase 2
Responsibility: Project QA Coordinator
Project Description: The project encloses production, utility, lab and office area. As Project QA Coordinator, responsible for qualification/operation strategy of GMP relevant equipment/utility.
2008/10 – 2011/01: QC Lab Extension Project
Responsibility: Project Team Lead
Project Description: Overall the project management coordinates with cross function departments, establish the project schedule with management team, and coordinate the project purchasing, training.
Education Background
2003/09 – 2007/07: North China University of Technology
Training Experience
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