Phong Tien Nguyen

Key Responsibilities

• Production & Maintenance: Track KPIs, analyze data, and implement efficiency & cost optimization solutions. Plan and execute preventive maintenance to ensure stable operations.
• Quality & Compliance: Drive RCA, CAPA & audits, ensuring adherence to 5S, GMP, EHS & quality standards
• Team Management: Lead a team of Engineers, Technicians & Operators, ensuring efficiency & timelines. Develop Qualification Matrix, PDR, KPIs, and provide SOP/FMD training.

Additional Responsibilities

• Training & Documentation: Review & update SOPs and work instructions.
• Process Improvement: Lead Six Sigma & Lean projects, reducing downtime & enhancing production quality.

• Revised local procedures to align with international ISO updates.
• Managed and maintained the Validation Master Plan, report to Plant Manager and global Quality
• Reviewed and approved all validation documents to ensure compliance.
• Provided methodological support for validation teams in TK, Molding, Assembly, Packaging, and EO Sterilization, Gamma irradiation
• Ensured the valid state of sterilization processes, focusing on EO Sterilization & Gamma Irradiation.
• Supported and implemented Computerized System Validation (CSV) & Data Integrity projects.

• Managed risk assessment for sterilizers and desorption chambers.
• Led qualification & validation activities for sterilization and desorption processes.
• Oversaw quality documentation, including sterilization batch records & relevant certifications.
• Monitored sterilization quality and addressed process-related issues.
• Collaborated with local & global teams on related projects.
• Reviewed and updated SOPs to ensure regulatory compliance.
• Participated in internal & external audits to maintain quality standards.

• Led a team, managing sterilizer qualification & validation activities.
• Planned and executed clean room validation to ensure compliance with regulatory standards.
• Supervised qualification & validation processes for laboratory equipment.
• Controlled documentation management and coordinated audit responses.
• Conducted Kaizen & improvement.
• Conduct gap analysis and implement compliance strategies to adapt to changing ISO standards