Quality Assurance Specialist (Yearly Contract)

About the Role

Are you ready to safeguard product quality and patient access by elevating GMP/GDP excellence across Thailand? In this role you will shape and deliver a unified quality system that underpins launches, market expansion, and reliable supply for the full portfolio in-country. You will join a trusted network of experts and report to the Director of Marketing Company Operations Quality, focusing on technically and strategically important work—building resilient systems to accelerate new product introductions while ensuring uncompromising compliance.

Responsibilities

• Batch Release and Pack Conversion: perform final documentation and packaging checks, execute release actions (paper and SAP), and ensure right-first-time quality to enable on-time supply.
• Product Quality Control and Product Security Leadership: coordinate intake, triage, and resolution of product quality complaints and product security cases, including communication with customers and manufacturing sites and shipment of samples.
• Quality Management System Implementation and Maintenance: embed, maintain, and continuously improve the local Quality Management System in alignment with One AZ QMS to drive consistency and control across GMP/GDP activities.
• Issue Management and CAPA Execution: lead deviation investigations and CAPA plans, produce clear investigation reports, and implement robust preventive actions to reduce recurrence and risk.
• Standards and SOP Governance: maintain local SOPs and standards, ensuring alignment with global policies and local regulatory requirements to deliver consistent, audit-ready processes.
• Stakeholder and External Third-party Collaboration: partner with third-party logistics service providers, global supply, and internal functions to resolve issues quickly, close documentation gaps, and assure end-to-end GDP compliance.
• Regulatory Inspections and Audits: support preparation, hosting, and response activities for health authority and internal inspections; implement effective self-assessment programs to sustain readiness.
• License to Operate and KPI Delivery: drive affiliate GDP quality excellence, meet country quality objectives, and contribute to performance metrics that reflect safe, reliable patient supply.
• Continuous Improvement and Problem Solving: anticipate future quality needs, troubleshoot complex issues, and recommend improvements that strengthen compliance and business continuity.

Qualifications

Essential Skills/Experience:

• Degree level or equivalent
• Experience of Good Manufacturing Practice (GMP) and/or Good Distribution Practice (GDP) in a Quality environment
• Strong communication and influencing skills and proactive communication with internal and external stakeholders
• Understanding of implementation and maintenance of the Quality Management System
• 1–3 years of experience in the quality department in a pharmaceutical company

Desirable Skills/Experience:

• Experience using SAP for batch release and documentation
• Hands-on coordination with third-party logistics service providers and external service providers
• Experience handling product quality complaints and product security cases, including sample management and feedback coordination with production sites
• Experience supporting GMP/GDP audits, inspections, and self-assessment programs
• Proven capability in deviation investigations, CAPA, and issue management
• Experience maintaining local SOPs and aligning with global standards
• Knowledge of Thai regulatory requirements for importation and distribution
• Fluency in Thai and proficiency in English

About the Company

Join a community where specialist expertise shapes decisions across the enterprise and directly impacts patients’ lives. Work with collaborative, cross-functional teams that balance agility with the rigor demanded by regulated environments, and benefit from investment in growth and development to deepen your craft and influence how quality enables launches and access in Thailand.

Additional Information

If you are ready to raise the quality bar for patients across Thailand and leave a measurable mark on launches, compliance, and supply continuity, send your resume to apply.