10 дней назад
Supply Operations Quality Senior Associate (Pharmaceuticals)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Supply Operations Quality Senior Associate (Pharmaceuticals): Supporting and maintaining Pfizer's Quality Management System for product supply operations in Vietnam with an accent on GMP/GSP compliance, audits, quality risk management, and regulatory requirements. Focus on coordinating inspections, deviations, CAPAs, product releases, supplier oversight, and compliant handling of repackaging, quarantine, complaints, and market actions.
Location: Ho Chi Minh, Vietnam; hybrid work arrangement
Company
is a pharmaceutical company operating product supply activities through country offices and regulated supply-chain partners.
What you will do
- Support, maintain, and implement the Quality Management System across the Vietnam country office.
- Coordinate quality activities with regulatory, supply-chain, medical, manufacturing, and external packaging stakeholders.
- Monitor quality KPIs, identify trends, support Quality Review Meetings, and coordinate quality risk management activities.
- Prepare for Health Authority inspections, internal audits, self-inspections, and supplier audits; track actions to completion.
- Support product release, repackaging and relabelling, quarantine shipment management, market actions, and complaint handling.
- Participate in deviation investigations and implement corrective and preventive actions, escalating significant product-quality or patient-safety concerns.
Requirements
- Tertiary education in Pharmacy and at least five years of pharmaceutical-industry experience in a quality role.
- Registered Pharmacist with the Vietnam Pharmacy Board, holding a valid pharmacy practice certificate covering pharmaceutical and/or vaccine export and import and storage services.
- Experience with Vietnam Pharmacy Law 2016, GMP, GDP, Vietnam GSP, and Quality Management Systems.
- Fluent written and verbal English and Vietnamese with business proficiency.
- Technical writing, reporting, stakeholder influencing, quality-system administration, and strong Word and Excel skills.
- Experience with electronic documentation control systems; TrackWise and eQMS experience is beneficial.
Culture & Benefits
- Hybrid work arrangement in Ho Chi Minh, Vietnam.
- Cross-functional collaboration across regulatory sciences, global supply chain, medical, manufacturing, and external partners.
- Opportunity to contribute to quality culture and quality-system improvements across the organization.
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