Pham Thi My Le
Quality Assurance Manager
TP.HCM
Summary
Interests: Passionate about discovering new technologies, experiencing different cultures, and meeting new people.
Working Principles: Focused on solving complex problems at the root cause and striving for excellence in product quality. Goal in the workplace is to ensure high-quality product delivery.
Overview
11
11
years of professional experience
2014
2014
years of post-secondary education
Work History
Deputy QA Manager and Deputy Qualified Person
Imexpharm Corporation
06.2023 - Current
- Contributed to the organization and structuring of QA operations, including organizational chart design, job descriptions, staff training, and the establishment of standard operating procedures.
- Participated in the preparation for and hosting of external inspections to ensure compliance with EU GMP and WHO GMP standards.
- Managed quality-related documentation for drug registration dossiers, both for domestic and international markets.
- Ensure the supervision of production, warehouse, QC, and technical activities is in accordance with regulations.
- Monitoring product quality across the entire lifecycle – from raw material input, through in-process controls, to final batch release.
- Managing pharmacovigilance activities, including ADR reporting, product recalls, and customer complaint handling, in compliance with GMP requirements.
- Authorized person for the batch release of finished pharmaceutical products manufactured locally, in compliance with GMP regulations.
- Ensure the quality management of manufacturers and external services.
Deputy Manager of the R&D Department
Imexpharm Corporation
08.2019 - 05.2023
- Participated in the organization of R&D department operations, including organizational chart development, job description definitions, staff training, and the establishment of standard operating procedures (SOPs).
- Ensure the implementation of product development research that aligns with expertise and relevant regulations.
Deputy Production Manager
Imexpharm Corporation
05.2019 - 08.2019
- Contributed to the organization of the Manufacturing Unit, including organizational chart design, job description development, staff training, and establishment of standard operating procedures (SOPs).
- Executed manufacturing activities in accordance with the production plan and GMP requirements.
- Trained personnel and monitored manufacturing processes to ensure product quality compliance.
- Supervised daily operations and implemented corrective and preventive actions (CAPA) to address deviations and prevent process-related issues.
Production Team Leader
Imexpharm Corporation
02.2018 - 05.2019
- Assigned personnel and supervised GMP compliance across all manufacturing areas.
- Prepared and maintained manufacturing documentation.
- Reviewed and compiled batch manufacturing records (BMRs).
- Developed and executed process validation and equipment qualification protocols to support continuous improvement and compliance.
R&D Team Leader
Imexpharm Corporation
12.2017 - 02.2018
- Received, managed, and executed pharmaceutical R&D projects.
- Reported on research progress and product development outcomes.
Regulatory Affairs Specialist
Imexpharm Corporation
07.2014 - 12.2017
- Prepared product registration dossiers.
- Responded to inquiries and provided justifications to the Drug Administration of Vietnam (DAV).
- Monitored and reported on product registration activities.
Education
Bachelor of Pharmacy (B.Pharm) -
Can Tho University of Medicine And Pharmacy
Skills
Professional English language skills: Level C certification
Training & Certificates
- Management Skills – PACE Business School
- Advanced GMP: 3 Key Quality Techniques (Contamination, Cross-contamination, Mix-ups)
- Time Management Skills
- Workshop on Drug Registration Dossier Preparation – Hanoi University of Pharmacy
- Basic Training on DSC (Theory & Practice) – Saigon Pharmaceutical Science & Technology Center (SAPHARCEN)
- ISO 9001:2015 – Instant Efficiency – Tran Dinh Cuu Consulting Co., Ltd.
- Seminar on Technical Development in R&D of Pharmaceuticals – Ho Chi Minh City Drug Quality Control Institute
- WHO TRS 1025 (2020), Annex 7: Good Storage and Distribution Practices
- EU GDP Guidelines (5 Nov 2013): Good Distribution Practice for Human Medicinal Products
- Cleanroom Microbiology for Sterile Manufacturing (2023)
- 2023 Forum on Process Verification and Validation Updates
- 2024 ISPE Aseptic Conference (March 12–13, 2024, Vienna & Virtual)
- Assessment of GMP Compliance for Overseas Manufacturers
- Advanced Excel & Dashboard Reporting – Start Train
- Key Issues in Drug Development & Registration Dossier Preparation – Vietnam Pharmaceutical Enterprises Association
- Updates on EU/WHO/FDA Guidelines for Validation
- EU-GMP Seminar – co-hosted by VNPCA & ISPE Singapore
- Manager as Coach – LCV Emotional Intelligence Program
- Management Capacity for Middle Managers – PACE Business School
- AI Application to Boost Performance (Prompt Engineering) – NOVALICHES Training & Consulting Co., Ltd.
Timeline
Deputy QA Manager and Deputy Qualified Person
Imexpharm Corporation
06.2023 - Current
Deputy Manager of the R&D Department
Imexpharm Corporation
08.2019 - 05.2023
Deputy Production Manager
Imexpharm Corporation
05.2019 - 08.2019
Production Team Leader
Imexpharm Corporation
02.2018 - 05.2019
R&D Team Leader
Imexpharm Corporation
12.2017 - 02.2018
Regulatory Affairs Specialist
Imexpharm Corporation
07.2014 - 12.2017
Bachelor of Pharmacy (B.Pharm) -
Can Tho University of Medicine And Pharmacy
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