Healthcare Quality & Regulatory Advisor
$113,000–$140,000 year
On-siteBangkok Yai, Bangkok, Thailand
Job Summary
Drive compliance and quality programs for Healthcare Transportation by determining policies, writing SOPs, and managing CAPA processes to ensure adherence to GDP, GCP, and cGMP standards. Lead internal and certification audits across regional hubs, validate cold chain facilities and packaging systems, and liaise with customers to resolve quality issues via root cause analysis. Support the Healthcare Quality Management System as an eQMS Super User while consolidating feedback for customer agreements and RFQ proposals. Based in Thailand, this role requires 5–7 years of experience in pharmaceutical transportation quality and regulatory affairs.
Required Qualifications
- 5 -7 years of relevant experience in Transportation, quality + QMS for pharmaceutical / healthcare industry in quality related role
- Experience working in airport
- good understanding on cold chain transportation compliance
- competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis
- working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices
- Experience in conducting external and internal audits for Japan warehouse in healthcare industry
- This role is to be based in Thailand
- Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards
- Problem-solving skills to support customer issue resolution
- Planning & organization skills to ensure proper audit programs are managed effectively
- Communication skills to facilitate engagements with customer and regulatory agencies
- Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking
- Apply data-driven decision making with the use of data analytics and visualization tools like Power BI
- competency in Microsoft Office applications like Excel, Word, and PowerPoint
Desired Qualifications
- Bachelor's degree, English major preferred
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