
Timeline
About me
Quality Management System Auditor and Consultant || Lean Six Sigma Operation Excellence
Education

Collin college
2008 - 2010Associate in science chemistry, pre-pharmacy associateActivities 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 - 2008High school diploma core curriculum 10th - 12thActivities and Societies: Advanced Chemistry Class

Nguyen du middle school
2001 - 2005Diploma chemistry 6th - 9thActivities and Societies: Advanced Chemistry Class

Texas christian university
2010 - 2016Bachelor of science chemistry, pre-pharmacy undergraduateActivities and Societies: Chemistry Club Honors College student
Experience

Texas a&m university-commerce
Jun 2010 - Aug 2010Undergraduate researcherDoing extensive research on organometallic

Washington state university
Jun 2011 - Aug 2011Summer research fellowSummer Undergraduate Research on Pharmaceutical Sciences

Texas christian university
Aug 2011 - Dec 2011Undergraduate student researcherJanesko Research GroupResearch on Theoretical/ Computational Chemistry

Uspharma usa
May 2012 - Aug 2012R&d intern_ on-hand practice laboratory techniques_ GMP-WHO procedural guidelines

Us pharma usa co., ltd.
Oct 2013 - Aug 2014Regulartory 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 2016Research 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 2016Research fellowSynthesize protein substrate by utilizing HPLC

Vietnam-us society (vus) international
Jan 2017 - Jul 2017English 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 2019Quality 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 2022English teacher_ Teaching ESL to students from various group age using accredited course books (INSIDE) designed by National Geography Press
.webp)
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 2021QC Equipment Specialist
Jan 2019 - Nov 2020

Abbott
Jan 2022 - Oct 2023Supplier 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 2025Quality consultantThe 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
- View certificate

Lean six sigma foundations
LinkedinSept 2024 - View certificate

Statistics foundations 1: the basics
LinkedinOct 2024 - View certificate

Become a six sigma yellow belt
LinkedinOct 2024 - View certificate

Operational excellence foundations
LinkedinOct 2024 - View certificate

Six sigma foundations
LinkedinSept 2024 - View certificate

Lean six sigma: define and measure tools
LinkedinOct 2024 - View certificate

Process improvement foundations
LinkedinOct 2024 - View certificate

Six sigma: white belt
LinkedinSept 2024 - View certificate

Lean six sigma: analyze, improve, and control tools
LinkedinOct 2024 - View certificate

Duolingo french fluency: beginner (estimated)
DuolingoJul 2016
Volunteer Experience
Volunteer Staff
Issued by American Center in Ho Chi Minh City on May 2014
Associated with Hieu TranRecording Officer
Issued by Phi Theta Kappa on Oct 2009
Associated with Hieu Tran
Languages
- viVietnamese
- amAmerican english
- frFrench
- spSpanish
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