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AstraZeneca

Quality Assurance Specialist (Yearly Contract)

1-3 Years
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  • Posted 5 days ago
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Job Description

Introduction to 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. Your decisions will directly protect patients and strengthen our license to operate.

You will join a trusted network of experts and report to the Director of Marketing Company Operations Quality. Here, the emphasis is on technically and strategically important work—building resilient systems, not chasing timesheets or sales quotas. How would you design a quality framework that accelerates new product introductions while ensuring uncompromising compliance

  • 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 ensure robust preventive actions that 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 - Logistic service provider, 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.

Essential Skills/Experience:

  • Degree level or equivalent
  • Experience of Good Manufacturing Practice and/or Good Distribution Practice in a Quality environment
  • Strong communication and influencing skills
  • 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 - Logistic service provider 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

Why AstraZeneca:

Join a community where specialist expertise shapes decisions across the enterprise and directly impacts patients lives. You will work with collaborative, cross-functional teams that bring diverse perspectives into the same room to spark bold thinking, balancing agility with the rigor demanded by regulated environments. We invest in growth and development so you can deepen your craft, try new ideas, and influence how quality enables launches and access in Thailand. We value kindness alongside ambition, giving you the freedom and accountability to deliver meaningful outcomes with the resources to make them happen.

Call to Action:

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 us your resume and show us the impact you want to make!

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About Company

Job ID: 148968261