Experience

Mary Kay China

• China
• Personal Care Product Manufacturing
• 1 - 100 Employee

• Senior Manager, Quality

  • Sep 2012 - Present

  ● Provide leadership on Quality control and management to ensure manufacturing and products in compliance with the requirement of cGMP and MK corporations. ● Effectively lead the investigation and risk assessments on quality issues, deviation, non-conformance, audits findings and drive CAPA and effectiveness verification. ● Lead validation team to provide process and cleaning validation and qualification activity of production equipment/facility/utility within MK China plants, and ensure practices performed as per approved procedures. ● Lead hygiene team to set up hygiene management system of product and environment in MK China to align with MK Global Quality policies and GMP requirement. ● Manage test method development, validation, verification and ensure testing proficiency, data accuracy and compliance. ● Surveillance of national and internal regulatory and pharmacopoeias, and set up implement actions based on complex regulatory situation. ● Work with SQM to conduct OEM/Ingredient/Compoment supplier audits for qualifying quality managemeng system and quality lab system. ● Work with RA to provide training course of MK quality control and management to China FDA. ● Long term plan the development of Quality Control organization, provide development and training/coaching opportunity to staff. ● Establish and implement a KPI structure to ensure optimal test /cost ratio to improve lab efficiency.■ Key Achievements 1. Established quality lab capability for new color plant and new nutritional plant.2. Established validation system of MK China for both Cosmetics and Nutritionals.3. Established new Microbiology R&D lab and built up research capability.4. Acquired the Certificate of Six Sigma Green Belt by delivering 300k RMB cost saving per year.5. Achieved First Prize in WCOM campaign by delivering 200k RMB cost saving per year.6. Led Project VSM to improve lab efficiency.7. Established new 100k clean room of skin care plant.



Sterigenics

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Technical Manager

  • May 2008 - Aug 2012

  • Manage Microbiology & Analytical laboratories and make sure the quality system, procedure and operation to meet the requirement of ISO 17025 and GLP.• Lead technical team to provide qualified sterilization service of medical device products and microbiological and analytical testing service.• Build and develop team skillbase and identify the market technical needs and cooperate with marketing teams to develop the new laboratory testing method for the local market.• Research on the link between medical device product materials/package configuration and sterilization type, and lead technical team to design and conduct tailored sterilization program for customers.• Responsible for the qualified sterilization validation performed & completed and smoothly transferred to production team.• Responsible for implementing the lab sales strategy to optimize the relationship with clients and achieve maximum results. • Organize and provide medical device-microbiology/sterilization/standards seminar & training for existing and potential clients.• Set up personal development plan for subordinates, and allocate their responsibilities to achieve the individual and team objectives.• Proactively affiliate with relevant industrial authority and standard committee, and participate in state standards meeting of medical device sterilization.



Unilever

• United Kingdom
• Manufacturing
• 700 & Above Employee

• Assistant Manager R&D

  • Nov 2002 - May 2008

  • Build up good collaboration with Home&Personal Care (HPC) formulation team and provide qualified microbiology technical support to meet HPC business needs in China.• As global contact person in China, involved in establishing hygiene security SOP and take responsibility of hygiene assurance for R&D and facility according to the global strategy. • Establish microbiological testing methodology of pathogenic bacterial screening and identification of foods formulation for foods development department and global supply chain.• Involved in foods product and process design in terms of microbiological safety and stability with respect to inactivation of pathogens and spoilage micro-organisms.• Set up antimicrobial screening models and perform micro assay to screen the TCM actives to support Project Hair and Deo.• Lead and delevop the skillbase and capability, and ensure the lab testing, equipment calibration and documentation to meet GLP requirement.• Lead Project Hair-dandruff by good communication with hair formulation team and draw up well-regulated work plan to completely meet requests and requirements of internal customers.



Institute of Biochemistry and Biophysics PAS

• Research Specialist

  • Jul 1999 - Nov 2002