To Bac

Quality Assurance and Compliance professional with progressive experience in pharmaceutical distribution and healthcare industry. Strong background in GxP Quality Systems, Data Integrity, Quality Risk Management, computerized systems, validation, and quality governance. Experienced in leading quality initiatives, managing quality operations, developing SOP and training programs, supporting audits and inspections, and collaborating with cross-functional teams to drive compliance, operational excellence, and continuous improvement.

Assistant Manager, Quality Assurance (AMQA) at DKSH Vietnam (2026-07 – Present)

• Lead the development and implementation of the company’s Data Integrity (DI) framework, including SOP establishment, training, and compliance oversight.
• Establish and implement Quality Risk Management (QRM) and Computerized System Validation (CSV) programs to strengthen GxP compliance and quality governance.

QA Supervisor at Zuellig Pharma, Vietnam (2024-08 – 2026-06)

• Managed validation activities and supported qualification and GxP documentation requirements.
• Participated in internal and external audits covering validation, qualification, and GxP-related documentation.
• Managed quality risk management and management review activities, including QMR and Quality Manual activities.
• Recognized as ZP Quality Ambassador.

QA/QC Supervisor at Zuellig Pharma, Vietnam (2023-11 – 2024-07)

• Led a team of 12 QA/QC personnel, overseeing daily quality operations, workload distribution, performance management, and employee development.
• Provided training and coaching on applicable procedures, GxP/GSDP requirements, and quality practices.
• Revised and maintained QA/QC SOPs and Work Instructions (WIs) to support compliant warehouse operations.
• Worked with clients to define and implement quality requirements for imported and wholesale healthcare products.
• Oversaw quality activities for a broad product portfolio, including medicinal products, clinical research products under GCP requirements, and medical devices.
• Managed and supported redressing and re-labelling activities for secondary packaging, including review and approval of client/internal re-labelling instructions and associated batch records.
• Verified product disposition and operational results, including storage conditions, to ensure compliance with approved requirements.

QA/QC Executive at Zuellig Pharma, Vietnam (2022-08 – 2023-10)

• Oversaw product quality inspection and disposition decisions for pharmaceuticals, medical devices, cosmetics, and dietary supplements,etc. ensuring compliance with regulatory requirements and internal quality standards
• Oversaw quarantined goods and retained sample management.
• Led and supported Computerized System Validation (CSV) activities for GxP-relevant systems, ensuring data integrity and compliance with validation requirements.
• Recognized with the ZPVN QA Best Performance Award 2023 for exceptional performance and contributions to quality excellence initiative

Clinical Research Coordinator at VietStars Biomedical Research (2022-06 – 2022-08)

• Coordinated study activities for sponsor-funded clinical research projects.
• Supported subject scheduling, study documentation, data collection, and investigator site activities.
• Collaborated with monitors and project teams to support study execution.
• Assisted study conduct at Ho Chi Minh City Oncology Hospital and Cho Ray Hospital in compliance with GCP requirements.

Research Assistant Intern at BIOCUBAFARMA, Cuba (2021-03 – 2021-12)

• Applied seven quality improvement tools to evaluate product quality using SPSS and Statgraphics.
• Participated in testing drugs and medicinal ingredients according to USP 41, including HPLC and UV-Vis.

Bachelor in Pharmaceutical Science – University of Havana, Cuba (2016-09 – 2022-01)