Senior Regulatory Affairs Specialist

• Jul 2022 - Present

Quality Specialist (Team Leader - Lab & Sterilization group)

• 2019 - Oct 2022

- Conducting annual Validation process for Large steam sterilizers and writing validation reports according to BS EN 285:2015 & ISO 17665:2006 Standards- Testing quality of finished products (Endotoxin, Bioburden, Extraction, Cleanliness) based on United States Pharmacopeia (USP) Chapter <85>, USP Chapter <161> & ISO 11737-1:2018 Standards- Controlling Cleanroom environment (Microorganisms in the air & Airborne particles) based on ISO 14644-1:2015, ISO 14698-1:2003 and the Japanese Pharmacopoeia 17th Edition (JP XVII) Standards- Collecting, analyzing data, writing monthly technical reports as well as authoring SOP’s to ensure the quality specifications- Reporting discovered defects and implementing nonconformance process through internal complaints and tracking system, including root cause and corrective actions based on ISO 14971:2019 & ISO 13485:2016 Standards- Calibrating laboratory equipment according to the annual schedule- Being an internal auditor - Evaluating regulatory requirements and overall compliance to identify, prevent risks and improve product quality- Training team members, setting annual plans and monitoring progress towards goals. Show less

Document Control Specialist (Document Control Group)

• 2019 - 2019

- Assisting in daily Document Control activities including storing, distributing and managing Drawings, Specifications, Device History Records, SOPs, Standards and Work Instructions- Adhering to the company's document life cycle procedures, archiving inactive records in accordance with the records retention schedule- Preparing quality documents for internal reporting and audits (TUV, Nikkiso Japan, internal NVM)

Sales Executive & Technical Support

• 2018 - 2018

- Ran demonstration experiments and support technical specifications of molecular biology chemicals and equipment - Conducted research market & managed customer relationships - Maintained up-to-date products’ knowledge through online webinars and conferences - Translated technical documents into Vietnamese language. - Ran demonstration experiments and support technical specifications of molecular biology chemicals and equipment - Conducted research market & managed customer relationships - Maintained up-to-date products’ knowledge through online webinars and conferences - Translated technical documents into Vietnamese language.

Senior Student & Research Assistant

• 2014 - 2016

- Carried out experiments and research according to protocols laid out by supervisor - Collected and log experimental data - Conducted statistical analyses of data sets - Prepared graphs and spreadsheets to portray results - Created presentation slides and posters to help researchers present findings - Reviewed print and online resources to gather information - Maintained laboratory equipment and inventory - Thesis: Comparative proteomic analysis of Vietnamese colorectal cancer tissue samples using two-dimensional polyacrylamide gel electrophoresis (2D-PAGE). => Found potential biomarkers by using 2D- PAGE - Project: Evaluating the adipogenesis of human adipose tissue-derived stem cells (ADSCs) in vitro. => Conducted ADSC stock culture, subculture and differentiation process of adipocytes in vitro. - Project: Research on over-expression of iridoviral protein ORF038 in E. coli. => Performed DNA cloning including culture microorganism in vitro and viral gene transformation into E. coli to develop vaccines. => Conducted experiment using molecular biology techniques (PCR, real-time PCR, gel electrophoresis, SDS-PAGE) Show less