Lng:
Tha Thun
a im: Thnh ph H Ch Minh - Tr s Chnh Hip Phc
Hn np h s: 27/08 26/09/2025
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Job Descriptions
Quality System Management (QA)
- Develop and improve the Quality Management System (QMS) based on Good Storage Practices (GSP), Good Distribution Practices (GDP), and Good Manufacturing Practices (GMP).
- Monitor environmental conditions and manage quality incidents, including deviations and non-conformances.
- Handle product quality issues, customer complaints, and product recalls. Investigate root causes and propose solutions.
- Conduct incoming goods inspections and make release recommendations.
- Manage equipment calibration, maintenance, and change control for GSP/GDP operations.
- Implement corrective and preventive actions (CAPA) to improve product quality.
- Ensure all necessary product legal documents are up-to-date and organized.
- Prepare for and participate in audits and self-inspections, including internal and external audits, and supplier evaluations.
Pharmacovigilance (PV)
- Manage all PV activities, including monitoring regulatory updates and coordinating with external partners.
- Handle Adverse Drug Reaction (ADR) reports and other safety updates, ensuring timely submission to national authorities and partners.
- Conduct training on PV and ADR reporting for staff and medical representatives.
- Respond to customer inquiries related to PV.
- Participate in investigations of counterfeit drugs.
Compliance & Operations
- Regularly update company policies and procedures, including drafting and revising Standard Operating Procedures (SOPs).
- Ensure compliance with GSP and GDP regulations by preparing and submitting applications and reports to government authorities.
- Organize and supervise drug destruction processes in compliance with regulations.
- Manage departmental assets, including budgeting and procurement.
Requirements
- Expertise: Deep knowledge of GSP, GDP, and PV.
- Skills: Strong teamwork, communication, and project management skills.
- Mindset: Highly responsible, detail-oriented, and able to work effectively under pressure.
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