YEOJEONG KWON

• Conducted data review and followed standard practices to find solutions.
• Conducted investigations into questionable test results
• Provide GMP guidance for QC Tech Transfer, Method Development and Method Implementation
• Review of Quality Management Systems (Dev, CC, CAPA etc.), Analytical Risk Assessments, and Method Validation documents regarding Tech Transfer
• Active communication with internal/external experts for MS&T data integrity enhancement and IND submission support
• Review of investigation records including exceptions and minor/major deviations for interim RS qualification, stability and MD(method development) documents
• Communication and decision making on method validation/transfer strategies and issues with 3rd party testing lab as client QA

- Provide guidance for MS&T, QC and CDO Tech Transfer and Method Implementation(Including but not limited to interim RS qualification, stability and MS&T SOP documents)

- Review of investigation records including exceptions and Lab investigations

- Preparation of IND documents and active Internal/external communication to provide regulatory guidance for preclinical stage stability studies and spec determination

- Review of QC analytical risk assessments, SOPs, method validation documents, and QMS records(change controls, lab investigations, exceptions etc.)

- Discussion on method validation/transfer strategies and issues with 3rd party testing labs as client QA