Sojeong Yang

Experience

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  Estechpharma Co Ltd

  Jan 2013 - Oct 2016

  Quality Engineer

  QMS (Change Controls and Deviations)- Managed change control in a timely manner, conducting a risk assessment with cross functional teams when the change control deemed as major or critical.- Managed deviations, performing product impact assessment and root cause investigationsDocument management- Issued batch records for manufacturing operations.- Contributed in management of lifecycle of documents by drafting, revising SOPs, and a wide range of specifications, and MBRsQualifications and Validations- Drafted protocols and reports of temperature mapping for storage areasTrainings- Managed annual training plan for all employees and conducted trainings for new employees and OJT (on-the-job-training). Show less

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  BioLeaders Corp.

  Oct 2016 - Oct 2017

  Quality Assurance Associate

  QMS (Change Controls and Deviations)- Managed nonconformances and ensured proper CAPA is in place thus contributing in preventing recurrence of similar incidents.Audits- Led internal audits as an auditor, conducted twice a year.Projects- Led a project to build up a comprehensive set of site level SOPs including quality manual.

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  Kangstem Biotech Co., Ltd.

  Oct 2017 - Apr 2019

  Quality Assurance Associate

  Quality Operations- Reviewed and approved QMSs including Change Controls, Deviations, CAPA- Managed deviations, performing product impact assessment and thorough root cause investigations, which includes application of various RCA (Root Cause Analysis) tools and statistical tools including 5M method, fishbone diagram, 5 whys, and statistical tools, followed by a proper CAPA plan.Document management- Drafted and revised specifications for raw and packaging materials.- Drafted and revised operational documents including but not limited to; Master Batch Records, BOM (Bills-of-materials), checklists for pre-operations, line clearance records, and label reconciliation records.Vendor Management - Conducted risk assessments for raw and packaging material vendors and grouped the vendors into three categories; high, medium, and low.- Participated in audits and follow ups for questionnaires sent out to vendors.- Drafted, reviewed, and approved quality agreements with CMOs- Led quality audits for CMOs and third-party-warehouses thereby ensuring they are in compliant with corporate policies/procedures and with applicable regulations.- Reviewed and approved transportation (shipping) validation protocols and reportsQuality Compliance- Conducted gap assessment of SOPs against latest European regulations and guidelines for ATMP (Advanced Therapy Medicinal Products)Projects- Led a project to build up a comprehensive set of site level SOPs including quality manual.- Led a project for Master Batch Record improvement thereby contributing in reducing human errors and variance across operators.- Contributed in defining and documenting roles & responsibilities for internal teams by leading weekly meetings for cross-functional teams. Show less

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  SK Biopharmaceuticals

  Apr 2019 - now

  QA Manager

  Quality Operations- Managed CMOs located world-wide, including Korea, and their quality activities for both drug substance and drug product, are compliant with cGMP/Eudralex/ICH and regulatory filings.- Reviewed and approved QMSs including Change Controls, Deviations, CAPAs delivered from CMOs- Notified clients/MAH (Marketing Authorization Holder) of deviations within an appropriate timeframe as dictated in the quality agreement.- Reviewed and approved CMOs’ documentation such as validation protocols/reports, MBRs, specifications, test methods, APQRs, etc.- Approved batch release by ensuring that all activities including batch record review, Change Controls/Deviations/OOSs are properly completed or investigated.- Setup a quality metrics thus the performance of CMOs can be reported/analyzed at a quarterly basis.- Led quality management review (QMR) sessions to report CMO performances, quality issues on a quarterly basisQuality and Third-party oversight - Reviewed and approved QMSs including Change Controls, Deviations, CAPAs delivered from CMOs- Reviewed, and approved quality agreements with CMOs- Participated quality audits for CMOs and third-party-warehouses thereby ensuring they are in compliant with corporate policies/procedures and with applicable regulations.- Reviewed and approved transportation (shipping) validation protocols and reportsProjects- Participated in tech-transfer project and provided quality insights especially in terms of compliance to regulations and filings, and reviewed/approved TTP/TTR, risk assessments, and relevant documentations.- Participated in a project to build up a comprehensive set of site level SOPs Show less