Senior Quality Assurance Executive

About the role

Egis Vietnam is seeking a Senior Quality Assurance Executive to set up and oversee the pharmaceutical Quality Management System for warehouse and distribution. The role ensures full compliance with Vietnamese regulations and GSP/GDP requirements and works closely with Logistics, Regulatory Affairs and global Quality teams during the transition to a new legal entity and GSP‑compliant warehouse.

Key responsibilities

• Ensure warehouse and distribution activities comply with GSP/GDP, local regulations and company standards.
• Develop, update and implement Quality SOPs, work instructions and records.
• Provide day‑to‑day Quality support to Warehouse and Logistics and act as main contact with Egis Group HQ for reporting, deviations/CAPA and global standards.
• Support the transition to the new legal entity, qualification of the new GSP warehouse, validation, temperature mapping and environmental monitoring.
• Investigate Quality issues, perform root‑cause analysis and drive CAPA and Change Control actions.
• Qualify and review 3PL, warehouse and logistics providers, monitor partner GDP compliance and manage related Quality issues.
• Maintain readiness for corporate and regulatory inspections, lead self‑inspections and support audit execution.
• Deliver GSP, SOP and Quality‑system training and coaching to ensure day‑to‑day compliance.

Required profile

• University degree in Pharmacy.
• Valid Pharmacy Practice Certificate covering import, storage and wholesale.
• 3–5 years experience in pharmaceutical QA, GSP/GDP and warehouse quality.
• Strong knowledge of SOP/document control, deviations, CAPA and Change Control.
• Experience with pharmaceutical warehouses and Vietnamese pharmaceutical regulations.
• Strong English proficiency (minimum B2, C1 preferred).
• Ability to work effectively with cross‑functional, local and global stakeholders.

Required skills

• SOP development and document control.
• GSP/GDP compliance management.
• Deviation investigation and CAPA management.
• Change control processes.
• Temperature mapping and environmental monitoring.
• Audit preparation and inspection readiness.
• Training delivery on quality systems.

What we offer

• Key role in a major business transformation in Vietnam.
• Opportunity to shape a new GSP pharmaceutical warehouse operation.
• Strong exposure to global Quality and transformation projects.
• Professional, collaborative environment with continuous learning.
• Competitive benefits package.