Senior Quality Assurance Executive
We are one of the leading generic pharmaceutical companies in Central Eastern Europe, and our activities incorporate all areas of the pharmaceutical value chain.
Egis Vietnam is looking for a Senior Quality Assurance Executive
who will be responsible for setting up and overseeing Egis Vietnam’s pharmaceutical Quality Management System for warehouse and distribution, ensuring full compliance with Vietnamese regulations and GSP/GDP requirements. The role closely cooperates with Logistics, Regulatory Affairs and global Quality teams during the transition to a new legal entity and GSP-compliant warehouse.
KEY RESPONSIBILITIES
- Quality System & GSP/GDP Compliance
Ensure warehouse and distribution activities comply with GSP/GDP, local pharmaceutical regulations and company standards
Develop, update and implement Quality SOPs, work instructions and records
Provide day-to-day Quality support to Warehouse and Logistics
Act as main contact with Egis Group HQ on reporting, deviations/CAPA and global standards
- New GSP Warehouse & Business Transition
Support transition to the new legal entity
Prepare the new GSP warehouse for qualification, inspection and go-live
Support qualification, validation, temperature mapping and environmental monitoring
Establish Quality processes for the new distribution model
- Deviations, CAPA & Quality Issues
Investigate Quality issues related to warehousing and transport
Perform root cause analysis and define/monitor CAPA
Participate in Change Control and drive recurring-issue improvements
- Product Storage & Distribution Quality
Ensure medicines are received, stored, handled and dispatched under approved conditions
Personally oversee and approve critical warehouse activities (receipt/release, quarantined/rejected/expired stock, returns, recalls)
Support FEFO, batch traceability and product-status control across the distribution chain
- 3PL & Logistics Quality
Qualify and regularly review 3PL, warehouse and logistics providers
Review Quality Agreements and monitor partner GDP compliance and performance
Manage Quality issues and CAPA related to outsourced activities
- Audit & Inspection Readiness
Maintain readiness for corporate and regulatory inspections, including prepare documentation and lead self-inspections,
Support execution of audits and follow up on findings
- Training & Quality Culture
Deliver GSP, SOP and Quality-system training and coaching to ensure day-to-day compliance
- Quality Performance & Improvement
Monitor key Quality indicators (deviations, CAPA, temperature excursions, supplier performance, training, audit findings)
Prepare regular Quality reports
Identify and implement process improvements while maintaining compliance
QUALIFICATIONS & EXPERIENCE
University degree in Pharmacy
Valid Pharmacy Practice Certificate (scope: Import, Storage & Wholesale)
3–5 years in Pharmaceutical QA, GSP/GDP, warehouse Quality
Strong knowledge of SOP/document control, GSP/GDP, deviations & CAPA, Change Control
Experience with pharmaceutical warehouses and Vietnamese pharmaceutical regulations
Strong English (min. B2, C1 preferred), written and spoken
Ability to work effectively with cross-functional, local and global stakeholders
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
Our mission is to serve people with all of our skills, ensuring that they live a long and healthy life.