Mô tả công việc
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
The role 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
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Training & Quality Culture
- Deliver GSP, SOP and Quality‑system training and coaching to ensure day‑to‑day compliance.
8. 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.