Experience

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  Hoya vision care

  Sept 2014 - Sept 2015

  Technical engineer

  - Researching and developing new working methods, components, products and manufacturing processes.- Installing process machineries, equipments, new products & new materials. - Data analysis, material analysis.- Cost reduction, production yield improvement, process optimization

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  Terumo blood and cell technologies

  Sept 2015 - now

  - Launch new products and coordinate significant product changes.- Transfer products from other Terumo BCT sites to TBV and performing product testing as necessary, facilitate product verification activities- Coordinate closely with engineering teams globally (U.S, Japan and India) on product changes, new product introduction, product quality resolution.- Coordinate implementation of product changes between U.S and the manufacturing team in Vietnam- Learn to effectively work in a factory were the cultures of Vietnam, India, Japan, Northern Ireland and America all come together.- Lead and is accountable for projects and drives results, guides the successful completion of major programs and function in a project leadership role.- Apply technical expertise to complex tasks with in-depth knowledge of related work areas- Provide broad-based direction for subordinates and colleagues within functional area and cross functionally- Learn and adhering to GMP practices and FDA regulations- Learn new production technologies and processes, support the expansion and addition of new manufacturing processes- Support the long-term strategic plan and build goals for the factory- Support development of product specifications and requirements- Support quality improvement projects Show less - Perform a wide variety of activities to ensure manufacturing and batch records of finished packaged product for intermediate and final disposition are in compliance with internal procedures in addition to applicable regulatory requirements by conducting batch record review, audits, data analysis, and other documentation reviews.- Work in detail, and recognize critical attributes, steps and functions relating to manufacturing processes and/or laboratory activities.- Communicates with appropriate personnel on missing required documentation, error corrections or other required documentation.- Ensure all deficiencies have been appropriately corrected/resolved to meet target shipment dates.- Track review, corrections, and resolutions for trending and metrics.- Manage batch records and related Certificate (Analysis and Compliance) in archive room.- Follow up the validation status and change control to ensure the validated processes and criteria are applied into production.- Perform monthly spot check and GEMBA Walk; report in Quarterly Management Review.- Support external audits (Customer, BSI, FDA..) for batch record/ release/ process control/ product realization.- Support Quality Management Systems improvement and other lean projects by detect the potential risks in processes and monitoring weekly/monthly/yearly right-first time status and deep-dive data analysis.- Participate in process improvement initiatives targeting for Right First Time (RFT).- Manage a team of 15 members Show less

  • Product Development Engineer

    Apr 2021 - now

  • Product Release Supervisor - Quality Assurance

    Sept 2016 - Apr 2021

  • Production Control

    Sept 2015 - Sept 2016