HAO RAN LOW

Practicing:
- ISO 9001:2015
- ISO13485:2016
- Good Distribution Practice (GDP)
- Good Distribution Practice for Medical Device (GDPMD)
- current Good Manufacturing Practice (GMP)

Job scope:
Responsible for providing Quality Assurance oversight to Business Unit Healthcare and for ensuring company’s Pharmaceutical and Medical Device operations are in compliance with requirements of local Regulatory Authorities and ISO standards, including:
- Manage Quality Assurance team for efficient performance
- Ensure Quality Management System (QMS) is implemented and maintained
- Manage QMS documentation control
- Manage qualification & validation activities
- Oversee quality management of cold chain
- Oversee distribution activities under clinical trial program
- Involved in assessment and decision to quarantine or dispose of returned, rejected, recalled or falsified products
- Enroll in quality audits (regulatory, certification body and clients)
- Enroll in risk analysis and non-conformance management

Highlight/Achievement:

- Successfully support qualification activities of new distribution center

- Improve qualification activities of packaging and transport

- Improve clinical trial services by increasing client satisfaction

- Enhance awareness of electronic records requirements with 70 -80% of employees start practicing

Practicing:
- current Good Manufacturing Practice (cGMP)

Job scope:

- Manage production team and enforcing cGMP in production plant
- Troubleshoot production operation related issues
- Perform machine/equipment qualification and cleaning validation
- In-charge in production documentation (SOPs, batch records & logbooks)
- Handling QMS related concerns (risk assessment, change control, deviation, audit & CAPA)
- Involve in machine and equipment parts procurement

Practicing:
- current Good Manufacturing Practice (cGMP)

Job scope:

- Manage production team and enforcing cGMP in production plant
- Make planning for production line to meet monthly shipment target
- Arrange schedule for machine preventive maintenance and qualification
- Troubleshoot production operation related issues
- Monitor production yield
- Handling QMS related concerns (risk assessment, change control, deviation, qualification & validation, audit & CAPA)
- Handling production documentation (SOPs, batch records & checklist)
- Involve in machine and equipment parts procurement

Highlight/Achievement:

- Establish Computerized Dispensing System (from designing, building, qualification (CSV) to implementation)
- Establish Cycle Time Monitoring System
- Preparing proposal submission to NPRA on projects (New Manufacturing Plant, New Material Warehouse & Filter Water Plant) - proposal approved
- Enroll & accomplish in production scale up project
- Enroll & accomplish in production upgrading project (eBMR)