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Fresenius Kabi
- Quality Management Manager
2016 - 2017
• Was responsible for 3 markets: Vietnam, Cambodia, Myanmar for Quality & Vigilance system.
• Handled problems relating to product’s Adverse drug reaction (ADR) for Pharmaceuticals and Incidents for Medical Devices; collect and verify information/ reports about product’s ADR / Incidents from customers, and report to CSO & Health Authority as regulation, feedback the ADR assessment to customers/ relevant authorities.
• Customized & implemented the corporate QMS of Fresenius Kabi into the local QMS following GSP, GDP, GMP for re-packaging/re-labelling process.
• Conducted & lead the internal audit including CAPA management & continuous improvement.
• Managed & lead the external audits at all distributors/ logistics providers, third party audit and authority audit.
• Assured products circulated on the markets comply with local laws & regulatory, comply with all quality assurance principals.
• Handled quality product complaint and recall (carried-out mock recall).
• Managed of all changes in the organization (change control).
• Negotiated and maintained Quality Agreement.
• Planned, organized and trained for new staff, current staff on ISO9001, GxP
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Detmold Packaging
- Quality Assurance Manager
2015 - 2017
• Developed, maintained QMS including SOPs/WIs in the manufacturing complied with ISO 9001 and BRC standards.
• Handled customer complaint.
• Managed of all changes in the organization (change control).
• Evaluated supplier periodically.
• Conducted internal audit and lead external audit.
• Supervised all of stages of production process including on-line process inspection, GMP, housekeeping audit daily.
• Followed-up CAPAs during audit findings, production, storage, distribution and post-delivery.
• Authorized to decide to release or on-hold of finished product.
• Planned, organized and trained for new staff, current staff on ISO9001 and BRC standard.
• Monitored quality trend, quality objectives/ KPIs of all departments.
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Dksh
- Quality Assurance Manager
Miribel
2013 - 2014
• Covered the quality assurance matters of DKSH Healthcare Division in nationwide.
• Was responsible for the quality aspects within supply chain, e.g: arrival, storage, trade return, etc…
• Ensured the compliance to ISO 9001, ISO 13485, GSP, GDP, GMP for re-packaging/relabeling process and regulatory requirements relating to healthcare industry.
• Conducted internal audit. Leaded external audit includes client audit, authority audit and supplier audit.
• Prepared Validation master plan, reviewed validation protocol and approved validation report.
• Managed of all changes in the organization (change control).
• Followed up, monitored and managed CAPAs.
• Negotiated and maintained Quality Agreement.
• Planned, organized and trained for new staff, current staff on ISO9001, ISO13485, GxP.
• Monitored quality trend quality objectives/KPIs of all departments
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Zuellig Pharma
- Quality Assurance Executive
2008 - 2010
• Controlled the designed location in complying with quality standards and policies as required by principals, local authority, GSP, GDP and GMP for re-packaging/re-labelling process.
• Coordinated and given the instructions to concerned departments for the implementation of the quality standards and policies.
• Coordinated with other relevant departments for the execution of internal audit and preparation for external audit including client audit, authority audit and certification body audit.
• Handled customer complaint.
• Implemented, revised and updated SOPs following GxP, local regulatory, principals and customer requirements
• Followed up on CAPA.
• Performed periodic suppliers audit to make sure they meet company requirements/ specifications.
• Monitored quality trend quality objectives/KPIs of all departments.
• Trained for new staff, current staff on ISO9001, GxP.
• Monitored quality trend quality objectives/KPIs of all departments
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Otsuka Vietnam Co., Ltd
- Assistant to QA Manager
2003 - 2007
I. The first stage: Quality Control Staff
* Carry out microbiological, biochemist testing in raw materials, intermediate products and finished products in laboratory following GLP.
* Monitor working environment of all cleaning rooms at production department. II. The second stage: Promoted to Assistant to QA Manager
* Supervise all of stages of production process.
* Cooperate with relevant sections/ departments to find out the cause of nonconformity, to prepare CAPA report.
* Trained for new staff on WHO GMP, GLP, GSP including quality management system, internal quality audit, customer complaint, etc ...
* Handled customer complaint.
* Executed the periodical internal audit.
* Prepared, implemented, updated SOPs (Standard Operating Procedure), methods of testing compliance with WHO GMP, GLP, GSP
* Prepared Validation Protocol and executed Validation.
* Coordinated with relevant sections/department on controlling and managing the changes and revisions as defined in SOPs.
* Handled returned goods.
