Seongyong Lee
Senior Manager
Seoul
Summary
Dynamic Senior Manager with extensive experience at Hutem, excelling in validation project execution and GMP compliance. Proven track record in strategic planning and project coordination, leading to successful client audits. Expertise in I/OQ protocols and effective communication with cross-functional teams, ensuring timely delivery and operational excellence in PFS packaging lines.
Overview
2
2
years of professional experience
3
3
Languages
Work History
Senior Manager, Technical Service
Hutem
03.2025 - Current
- Managed end-to-end execution of validation projects for vial filling and PFS packaging lines, from requirement analysis to client approval and payment milestones.
- Developed and executed I/OQ protocols, ensuring compliance with GMP/cGMP standards.
- Conducted sampling and prepared validation documentation, leading to successful client audits and approvals.
- Led Factory Acceptance Testing (FAT) and coordinated with clients to ensure on-time project progression.
- Interpreted and applied GMP requirements (including aseptic processing and packaging) into validation documentation.
- Collaborated with cross-functional teams and suppliers to maintain timelines and prevent delays.
- Coordinated with Chinese suppliers and Korean customers, ensuring the on-time project progression with fully understood explanation and risk managements
Senior Manager, QA
Atechince
05.2024 - 02.2025
- Managed production scheduling for PFS packaging lines, ensuring timely delivery and efficient operations.
- Performed in-process QA activities including batch record review, line clearance, and deviation handling in compliance with GMP.
- Supported validation activities and ensured processes operated within defined parameters.
- Maintained accurate GMP documentation and contributed to audit readiness.
Education
Bachelor of Arts - International Business
University of LIverpool
Liverpool 04.2001 -
Skills
Strategic planning
Talent development
Operations management
Resource allocation
GMP / cGMP Compliance
Validation (IQ / OQ)
PFS & Vial Filling Line Operations
QA Documentation & Batch Review
FAT (Factory Acceptance Testing)
Project Coordination & Client Communication
Regulatory Document Interpretation (English)
Timeline
Senior Manager, Technical Service
Hutem
03.2025 - Current
Senior Manager, QA
Atechince
05.2024 - 02.2025
Bachelor of Arts - International Business
University of LIverpool
04.2001 -