Khaing Zar Thwe
Pharmacist
Overview
20
20
years of professional experience
Work History
Manager (Quality Assurance & Regulatory Affairs)
Grand Pharmaceuticals Co., Ltd., Yangon, Myanmar
08.2018 - Current
- Develops, implements and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.
- Reviewed and ensured that quality system processes and procedures were in compliance with all required standards and corporate policies.
- Identifies and sets appropriate quality standards and parameters for products.
- Communicates quality standards and parameters to QA team, product development team, and other appropriate staff.
- Continuously communicates with team members to ensure they are well informed about all issues affecting them and the members
- Provide Final fate of receipt goods whether to destroy, return or release after decision from authorized person
- Handling of Customer complaint and communicate with relevant department for proper root cause and preventive action for service complaint
- Responsible to conduct mock recall and perform promptly any recall operation of products
- Responsible to review validation, qualification and mapping protocol and report
- Preparing and applying all regulatory matters for drugs - DRC, DIAC registration, renewal, variation, notification processes, DIAC attachments in accordance with the timeline
- Preparing and applying all regulatory matters for medical devices
- Contact with the principals for any regulatory matters e.g. requesting dossiers, samples and any required documents
- Monitor and follow-up with health authorities on the progress of submitted cases for any required and additional documents
- Investigating regulatory impacts and requirements with health authorities according to the principals’ queries
- Visiting to FDA, Nay Pyi Taw for regulatory matters when needed
Pharmacist
Shwe La Min Hospital
09.2016 - 12.2017
- Dispensed and verified patient prescription orders, conducting necessary utilization reviews.
- Responsible for Good Storage Practice (GSP) such as storage, transportation and temperature sensitive items, regular inspections of displayed items on the shelves accordingly.
- Collaborated with pharmacy team members to develop and implement strategies for continuous improvement in quality of care.
Pharmacist
Food And Drug Administration (FDA)
02.2004 - 09.2008
- Checking and verifying the registration documents via registration guidelines, maintaining & updating of data records.
- Final checking and approving new products before they can be sold for public consumption including the content, labeling and packaging the products.
- Performed the quantitative and qualitative analysis of pharmaceutical products for registration.
- Participated in quality control reports for daily laboratory analysis of pharmaceutical substances.
- Maintained up-to-date knowledge on emerging pharmaceutical trends by attending conferences and completing continuing education courses.
Education
Bachelor of Science - Pharmaceutics, Pharmacology
University of Pharmacy
Myanmar 04.2001 -
Skills
Timeline
Manager (Quality Assurance & Regulatory Affairs)
Grand Pharmaceuticals Co., Ltd., Yangon, Myanmar
08.2018 - Current
Pharmacist
Shwe La Min Hospital
09.2016 - 12.2017
Pharmacist
Food And Drug Administration (FDA)
02.2004 - 09.2008
Bachelor of Science - Pharmaceutics, Pharmacology
University of Pharmacy
04.2001 -
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