Hieu Tran

Hieu tran

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location of Hieu TranHo Chi Minh City Metropolitan Area
Followers of Hieu Tran369 followers
  • Timeline

  • About me

    Quality Management System Auditor and Consultant || Lean Six Sigma Operation Excellence

  • Education

    • Collin college

      2008 - 2010
      Associate in science chemistry, pre-pharmacy associate

      Activities and Societies: Phi Theta Kappa Honors Society (Recording Officer) Student Government Association (SGA) (Campus Senator Chair) International Student Assiociation (ISA) IT/ Business Club (Treasurer)

    • Le hong phong high school for the gifted

      2005 - 2008
      High school diploma core curriculum 10th - 12th

      Activities and Societies: Advanced Chemistry Class

    • Nguyen du middle school

      2001 - 2005
      Diploma chemistry 6th - 9th

      Activities and Societies: Advanced Chemistry Class

    • Texas christian university

      2010 - 2016
      Bachelor of science chemistry, pre-pharmacy undergraduate

      Activities and Societies: Chemistry Club Honors College student

  • Experience

    • Texas a&m university-commerce

      Jun 2010 - Aug 2010
      Undergraduate researcher

      Doing extensive research on organometallic

    • Washington state university

      Jun 2011 - Aug 2011
      Summer research fellow

      Summer Undergraduate Research on Pharmaceutical Sciences

    • Texas christian university

      Aug 2011 - Dec 2011
      Undergraduate student researcher

      Janesko Research GroupResearch on Theoretical/ Computational Chemistry

    • Uspharma usa

      May 2012 - Aug 2012
      R&d intern

      _ on-hand practice laboratory techniques_ GMP-WHO procedural guidelines

    • Us pharma usa co., ltd.

      Oct 2013 - Aug 2014
      Regulartory affair officer

      _ Filing new drug registration with the Vietnam Drug Agency (VDA)_ Monitoring and extending validation of existing on-market brands.

    • Texas christian university

      Aug 2015 - Dec 2016
      Research assistant

      _ Annunziata Research Group (http://geo1.tcu.edu/annunziata/researchgroup.html)- Working on diffusion rate of methylene blue dye in agar gel

    • Texas a&m international university

      May 2016 - Aug 2016
      Research fellow

      Synthesize protein substrate by utilizing HPLC

    • Vietnam-us society (vus) international

      Jan 2017 - Jul 2017
      English lecturer

      _ Teaching ESL to students from various group age using accredited course books designed by Oxford University Press (OUP)

    • Savipharm joint stock company (j.s.c)

      Apr 2017 - Jan 2019
      Quality control analyst

      _ Coordinate and follow up with Active Pharmaceutical Ingredients (APIs) manufacturers to complete regulatory Drug Master File (DMF)_ Operate and analyze results of Infrared (IR) Spectroscopy, High-performance Liquid Chromatography (HPLC)_ Cross-check and double-check existing DMF to ensure compatibility with corresponding specifications and standard analytical procedures cited in reference pharmacopeias (USP, EU.Phar, IP, VP, etc)

    • Yola institute

      Jul 2017 - Jan 2022
      English teacher

      _ Teaching ESL to students from various group age using accredited course books (INSIDE) designed by National Geography Press

    • Davipharm (dat vi phu pharmaceutical jsc)

      Jan 2019 - Jun 2021

      _ Assign work and monitor team progress in meeting with factory manufacturing plan_ Build and evaluate team member KPI_ Ensure sampling and testing of raw material compliance with current SOP and GMP/EUGMP guidelines _ Track and perform equipment qualification in accordance with current SOP and GMP/ EUGMP guidelines_ Ensure GMP compliance and data integrity practice in GLP laboratory

      • QC Team Leader

        Nov 2020 - Jun 2021
      • QC Equipment Specialist

        Jan 2019 - Nov 2020
    • Abbott

      Jan 2022 - Oct 2023
      Supplier quality assurance

      • As Abbott Certified Auditor, conduct appropriate supplier evaluation (On Site/ Desktop Audits / Quality Questionnaires) for all suppliers for GMP system, including but not limited to API, Excipient, packaging and printed material and Service providers (Contract Laboratories, Pest Control Services, Engineering Services, Transportation services, etc)• Issuing Audit Agenda, Schedule(s), audit reports, Corrective Actions and Preventive Action (CAPA) plan, completion of audit closure.• Make risk-based decision to approve or reject supplier based of outcome of evaluation process• Develop and maintain status of the Approved Supplier List (ASL) and status of each supplier.• Establish and maintain Quality Technical Agreements with Suppliers• Assign the final risk classification to applicable Suppliers • Support site in investigation of Significant Events related to Suppliers & escalate the supplier quality issues to management. Show less

    • Elanco

      Oct 2023 - Feb 2025
      Quality consultant

      The purpose of the role is to provide Quality oversight on behalf of Elanco to the Merck MSD Dong Nai manufacturing facility for the for the duration of the Vietnam Letter Agreement. The role will ensure the site activities are in compliance with all quality regulations as required for operation under the Elanco manufacturing license.• Prepare and present an overview of the site quality status to a joint meeting with MSD and Elanco quality leadership• Perform independent reviews of documentation and operational activities.• Conduct periodic quality checks of manufacturing and laboratory testing activities, including review of certificates of analysis and associated deviations prior to batch approval• Review site quality metrics• Review any proposed change controls which impact the quality system • Support site in investigation of Significant Events related to Suppliers & escalate the supplier quality issues to management.Immediately report any suspected non-compliance to Elanco supervisor for review and evaluation of impact• Serve as point of contact for any regulatory inspections or communications Show less

  • Licenses & Certifications

  • Volunteer Experience

    • Volunteer Staff

      Issued by American Center in Ho Chi Minh City on May 2014
      American Center in Ho Chi Minh CityAssociated with Hieu Tran
    • Recording Officer

      Issued by Phi Theta Kappa on Oct 2009
      Phi Theta KappaAssociated with Hieu Tran