EI THIN ZAR MAUNG MAUNG (Eliana)
Quality Assurance
Singapore
Summary
Quality Assurance professional with over 10 years of experience in the Medical Device and Pharmaceutical industries across Singapore and Myanmar. Strong expertise in ISO 13485, ISO 14971/ISO 24971, ISO 9001, GSDP and HSA regulatory requirements, with proven experience in QMS implementation, regulatory compliance and quality system governance.
Experienced in supporting end-to-end quality operations across the medical device such as IVD and POCT (e.g., HbA1c and cholesterol monitoring devices), diagnostic reagents and controlled drug (DOA) products by ensuring product safety, compliance and supply chain integrity.
Skilled in managing cold chain logistics (vaccines and temperature-sensitive products) and non-cold chain pharmaceuticals with strong focus on risk-based quality management and deviation control.
Certified ISO 13485 Lead Auditor with hands-on experience in supporting regulatory inspections, supplier quality management, CAPA management and internal auditing for continuous improvement.
Overview
12
12
years of professional experience
6
6
Certifications
Work History
Quality Assurance Asst. Manager
SG Diagnostics Pte. Ltd.
01.2026 - Current
- Established and improved QMS (SOPs/WIs) in compliance with ISO 13485:2016, IEC 62304, and HSA requirements.
- Implement risk management activities in line with ISO 14971 including risk assessments (e.g., FMEA) and lifecycle monitoring.
- Oversee incoming, in-process, and final product quality control including returned goods.
- Manage non-conforming materials and ensure proper investigation, disposition and documentation.
- Drive CAPA, deviations and complaint handling, including trend analysis and effectiveness checks.
- Lead change control processes, ensuring proper impact assessment and timely closure.
- Review and manage supplier/OEM Quality Agreements and performance.
- Conduct internal audits as Lead Auditor and support external audits and regulatory inspections.
Quality Assurance Executive
SG Diagnostics Pte. Ltd.
01.2024 - 12.2025
- Created QMS related SOPs/WIs for manufacturing and distribution of Medical Device to comply with ISO 13485:2016 requirements
- Performed quality inspection and verification for incoming materials, dispatched products and returned products.
- Executed and supported validation and verification activities (e.g., IQ/OQ/PQ, method validation)to ensure compliance with product specifications, regulatory requirements and intended use.
- Participated in internal audits as the Auditor and ensure timely closure of findings.
Head of Quality Assurance
AA Medical Products Ltd., AMTT Co. Ltd. (Pacific AA Group)
03.2023 - 12.2023
- Key player in implementation and continuous monitoring of QMS, ensuring consistent quality of pharmaceutical products in compliance with ISO 9001 and Good Storage & Distribution Practice (GSDP).
- Managed cold chain handling processes to ensure proper storage, transportation, and distribution of temperature-sensitive products.
- Developed, implemented, and maintained QMS documentation (SOPs, protocols, WIs, and forms) in collaboration with cross-functional teams to meet regulatory and quality standards.
- Established Quality Policy and perform risk-based analysis including risk assessment and control activities.
- Liaised with principals/clients on quality-related matters and support external audits; participate in internal audit programs.
- Supported implementation of SHE (Safety, Health & Environment) systems and ensure regulatory compliance.
- Conducted quality training to enhance employee competency and monitor compliance across the supply chain through non-conformities, customer feedback and complaint handling.
Asst. Head of Quality Assurance
AA Medical Products Ltd., AMTT Co. Ltd. (Pacific AA Group)
03.2021 - 03.2023
Quality Assurance Manager
AA Medical Products Ltd., (Pacific AA Group)
04.2017 - 03.2021
- Established and maintained the Quality Management System (QMS) in compliance with ISO 9001:2015 and GSDP guidelines to ensure product quality across the supply chain.
- Implemented and managed the internal audit program, including audit execution, reporting of findings, and CAPA follow-up to drive QMS improvement.
- Managed change control processes, including deviation handling, root cause investigation, and evaluation of corrective and preventive action plans.
- Managed customer complaint handling process, ensuring timely investigation, resolution, and closure to achieve customer satisfaction.
- Maintained and controlled quality documentation and records to ensure compliance, traceability, and regulatory readiness.
Quality Assurance Executive
DKSH services Ltd., Myanmar
12.2015 - 03.2017
- Implemented Quality related validation, qualification testing protocols, plans (Temperature Mapping, Cold Chain Management system and packaging configuration test, Vehicle Testing, etc.)
- Prepared all reports of quality related Validation /Qualification and Testing process.
- Performed quality inspection of incoming arrival shipments, dispatch of cold chain products and handled reverse logistics.
- Executed and Monitored pest control process, Preventive Maintenance, Calibration process and maintained to comply with standard requirements.
Quality Assurance Coordinator
DKSH services Ltd., Myanmar
09.2014 - 12.2015
Medical Representative
AA Medical Products Ltd., (Pacific AA Group)
01.2014 - 09.2014
- Performed daily physician, hospitals, clinic visit as per plan
- Planned & executed in marketing related activities, promotion and market research
- Communicated with Physicians/ doctors, customers to declare about medical knowledge and information concerned with pharmaceutical products
- Analyzed and monitored the products of competitors in the market
Education
Master of Business & Administration - MBA
University of The Thai Chamber of Commerce, International School of Management (UTCC, ISM)
Thailand01-2022
Bachelor of Pharmacy - B. Pharm
University Of Pharmacy
Yangon, Myanmar01-2014
Skills
Results-oriented & Proactivity
Good Cooperation & Communication skill
Time Management & Capability to work under pressure
Deadline-driven and Adaptable
Strong analytical and problem-solving skills
Team Collaboration & Leadership
Training & Public speaking
English Language (4 skills)
Capability to write SOP/WI
Internal Auditing
Accomplishments
- Promoted as Head of QA from Asst. QA Head and from QA Manager.
- Achieved to get ISO for acquired new company under Pacific AA Group ,AMTT Co.Ltd. which provide Medical Device & Laboratory equipment distribution.
Certification
ISO 13485:2016 Lead Auditor – CQI/IRCA Certified
Timeline
Quality Assurance Asst. Manager
SG Diagnostics Pte. Ltd.
01.2026 - Current
Quality Assurance Executive
SG Diagnostics Pte. Ltd.
01.2024 - 12.2025
Head of Quality Assurance
AA Medical Products Ltd., AMTT Co. Ltd. (Pacific AA Group)
03.2023 - 12.2023
Asst. Head of Quality Assurance
AA Medical Products Ltd., AMTT Co. Ltd. (Pacific AA Group)
03.2021 - 03.2023
Quality Assurance Manager
AA Medical Products Ltd., (Pacific AA Group)
04.2017 - 03.2021
Quality Assurance Executive
DKSH services Ltd., Myanmar
12.2015 - 03.2017
Quality Assurance Coordinator
DKSH services Ltd., Myanmar
09.2014 - 12.2015
Medical Representative
AA Medical Products Ltd., (Pacific AA Group)
01.2014 - 09.2014
Bachelor of Pharmacy - B. Pharm
University Of Pharmacy
Master of Business & Administration - MBA
University of The Thai Chamber of Commerce, International School of Management (UTCC, ISM)