Summary
Overview
Work History
Education
Skills
Timeline
Generic

Yeo Ju Song

Senior Quality Assurance Manager
Incheon

Summary

Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.

Overview

14
14
years of professional experience
1
1
Language

Work History

Quality System Operations

Samsung Bioepis (Korea)
04.2014 - Current
  • Leading a project for establishing electronic Quality Management System(eQMS) including CSV and contributed on successful regulatory inspections from major Health Authorities, such as USA, EMA, Switzerland, Korea
  • Quality operations for cell bank/drug substance/secondary packaging manufacturing of sterile biological products in development/commercial stages (incl. technology transfer from pilot scale to GMP scale)
  • Collaboration with Qualified Person in EU and Responsible person in Switzerland and UK to establish global affiliate QMS and lead successful inspection outcome for health authority inspection on affiliates (EMA, Swissmedic)
  • Leading a function of Finished Drug Product responsible for QA operation and oversight of packaging GMP facilities in European countries, USA
  • QA supporting for global launches for EU/US/ROW markets
  • Trend monitoring compliance key indicators
  • Quality oversights at CMOs in EU/USA, batch releases and associated QA works (deviations, CAPAs, investigations, Change controls)
  • Successful QA supporting for global launches for EU/ROW markets
  • Regulatory support for IND, CTD for EU/US and ROW markets
  • Quality agreements creations & reviews/Quality SOPs creations, revision
  • Quality Compliance
  • Establishing Training policy/procedure for GxP training and management of annual training plan and training matrix
  • Performing Internal audit and hosting marketing partner’s audit and health authority (US FDA, EMA, Health Canada, Swissmedic)
  • Supplier audits as a lead auditor and as a co-auditor for cell bank, drug substance, raw material, finished drug product CMOs and testing lab
  • Assistant Manager in Quality Assurance
  • Quality operations for drug substance/secondary packaging manufacturing of biosimilar products in commercial stages
  • Quality operations for secondary packaging manufacturing of biosimilar product in clinical stage
  • Product related documents management i.e. Products/materials specifications creation/revision, deviation/change control, SOPs, annual product review, supplier quality index
  • Annual product reviews for finished drug products
  • Regulatory supports for CTD for ROW markets
  • Supplier audits as packaging materials suppliers, antibiotics manufacturing site
  • managing R&D laboratory with establishment of R&D quality procedure (reagent/material, documentation, equipment management)

Researcher, Bio-material Lab

Samsung Advanced Institute of Technology (SAIT)
02.2012 - 03.2014
  • Conducting research on developing microbial cell line which produce biodegradable plastics
  • Design and optimize vectors for improved production performance
  • Registered a patent related to biodegradable plastic production technology, contributing to intellectual property

Education

M.S. - Biological Jurisprudence

Korea University
02.2012

B.S. - Life science and biotechnology

Korea University
02.2009

Skills

Friendly, positive attitude

Teamwork and collaboration

Flexible and adaptable

Multitasking

Microsoft office

Microsoft Word

Problem-solving

Timeline

Quality System Operations

Samsung Bioepis (Korea)
04.2014 - Current

Researcher, Bio-material Lab

Samsung Advanced Institute of Technology (SAIT)
02.2012 - 03.2014

B.S. - Life science and biotechnology

Korea University

M.S. - Biological Jurisprudence

Korea University

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Yeo Ju SongSenior Quality Assurance Manager