Healthcare Quality & Regulatory Compliance Specialist (Hybrid) - AMEA
Location: Bangkok (Hybrid)
Reporting to: Manager Healthcare Quality & Regulatory Compliance
Job Purpose
Play a critical role in driving compliance and quality programs for Healthcare Transportation & Facilities. You will support the Healthcare Quality Management System to ensure all processes and systems are compliant with regional and local regulations and customer requirements.
Key Responsibilities
- Quality Management: Determine, implement, and promote policies and procedures for the Network and facilities to ensure compliance with GDP, GCP, and other industry standards.
- SOP & Documentation: Write and review SOPs and Work Instructions for transportation and fulfillment solutions within the healthcare industry.
- CAPA Management: Lead the process creation and review of documentation for Corrective and Preventive Actions (CAPAs), monitoring progress until closure.
- Audit Leadership: Support and lead internal audit programs, certification audits with regulatory agencies, and regular healthcare customer audit programs.
- Customer Liaison: Liaise with customers to understand quality requirements and resolve issues via root cause analysis.
- Validation: Lead and support the validation of transportation lanes and critical equipment, including cold chain facilities and packaging systems.
- System Support: Act as a Super User for the eQMS system and develop corresponding training programs.
Requirements
- Bachelor's degree in Pharmacy from a reputable local institute.
- Must hold a local Pharmacist License.
- 3 to 5 years of experience in a quality-related role within the pharmaceutical or healthcare industry.
- Working experience with cGMP, GCP, GDP, ISO13485 for Medical Devices, and IATA CEIV.
- Strong competency in Quality Assurance, Regulatory Affairs, and Root Cause Analysis.
- Good command of English
- Thai nationality only
