Summary
Overview
Work History
Education
Skills
Timeline
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Eunji Hong

Summary

From DNA cloning to Quality Assurance, my experience includes cell line development, cell culture of bacteria, animal cells and stem cells, purification, cell banking (RCB, MCB, and WCB), Process Validation, preparation of country-specific administrative documents, MAA/BLA submission support, response to Agencies' questions, launch support for US and ROW countries, and CMO quality oversight

Overview

8
8
years of professional experience
2
2
Languages

Work History

Quality Assurance

Samsung Bioepis
04.2021 - Current
  • Played a key role in new product launches by conducting thorough risk assessments and failure mode analysis, minimizing potential issues during production rollouts.
  • Ensured compliance with industry standards and regulatory guidelines for quality management systems.
  • Established strong relationships with suppliers, facilitating collaboration on quality-related matters and promoting adherence to specifications.
  • Specified quality requirements of raw materials with suppliers.
  • Reported production malfunctions to managers and production supervisors.
  • Assured consistent quality of production by implementing and enforcing automated practice systems.
  • Tracked quality issues with external customers, suppliers, and internal plant operations.
  • Supported the successful completion of external audits by diligently maintaining accurate records and documentation in accordance with regulatory requirements.
  • Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
  • Facilitated open communication channels between departments for sharing best practices related to quality assurance methodologies, driving organizational success as a whole.

Researcher

Samsung Advanced Institute Of Technology
03.2019 - 03.2021
  • Cell and Gene Therapy research

Researcher

Samsung Bioepis
08.2016 - 02.2019
  • Cell line development

Education

Ph.D. - Department of Biotechnology And Bioinformatics

Korea University
04.2001 -

Skills

  • Quality Assurance Compliance
  • GMP Quality Assurance
  • Product quality assurance
  • CMO quality oversight
  • Process validation

Timeline

Quality Assurance

Samsung Bioepis
04.2021 - Current

Researcher

Samsung Advanced Institute Of Technology
03.2019 - 03.2021

Researcher

Samsung Bioepis
08.2016 - 02.2019

Ph.D. - Department of Biotechnology And Bioinformatics

Korea University
04.2001 -

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Eunji Hong