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

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

1. 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

1. 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

1. 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

1. 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

1. 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

1. Training & Quality Culture

Deliver GSP, SOP and Quality-system training and coaching to ensure day-to-day compliance

1. 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.