Trách nhiệm chính

• Support, maintain and implement the Quality Management System (QMS) at Pfizer Country Offices in Vietnam
• Assist with timely implementation of applicable quality management systems (SOPs) within the PCO
• Ensure initial and continuous training programs are implemented and maintained for all relevant PCO colleagues
• Manage planned, permanent & temporary changes of GMP/GSP related activities & systems, ensuring proper documentation and completion within agreed timelines
• Collect key quality performance indicators, evaluate and highlight significant trends, and identify actions
• Monitor KPIs of the QMS, evaluate trends, and identify actions
• Lead and/or participate in Quality Review Meetings as required
• Provide support in preparation and coordination of Health Authority inspections and/or internal Pfizer audits of GMP/GSP activities
• Work with local cross‑functional team to define action plans to address inspection/audit observations and track implementation
• Participate in the self‑inspection program as an auditor and/or auditee
• Participate in the Quality Risk Management program for consistent application, documentation and communication of risks
• Assist in the local release process of products under the PCO’s distribution licence
• Support coordination of all product repackaging and/or relabelling activities in the PCO and at third‑party packaging sites
• Assist in Actions Quarantine Alert Notifications and manage quarantine shipments compliantly
• Provide support for any market action operation in the PCO
• Handle complaints: perform intake and triage, issue correspondence letters, act as contact point for regulatory agencies
• Participate in deviation investigations using appropriate tools and implement CAPAs
• Notify management of significant concerns or deviations within the QMS
• Assist with preparation of QRT meetings and implementation of local actions
• Assist in management of GxP suppliers, including qualification and quality oversight
• Ensure appropriate customer screening processes are in place
• Coordinate RQA audits at suppliers
• Assist in development and execution of objectives/projects consistent with SOQ Purpose Blueprint
• Assist in development and maintenance of quality culture within the team and organisation

Yêu cầu

• Minimum tertiary education in Pharmacy
• Minimum 5 years in the pharmaceutical industry in a quality role
• Registered Pharmacist with Vietnam Pharmacy Board with a valid pharmacy practice certificate and scope of export/import/storage
• Fluent in English (written & verbal) – business proficiency
• Fluent in Vietnamese (written & verbal) – business proficiency
• Experience in Vietnam Pharmacy Law 2016, GMP, GDP, Vietnam GSP and QMS
• Technical writing and reporting
• Excellent computer system skills – Word and Excel essential
• Experience with electronic documentation control systems advantageous
• Previous use of Trackwise®, eQMS beneficial

Hình thức làm việc

• Hybrid

Thông tin khác

• Position is full‑time
• Work location: Thành phố Hồ Chí Minh
• Applicants must submit applications only through official channels: Pfizer Careers website, verified LinkedIn page, and verified local job board – Pharma360
• No payment, bank details or confidential personal information is requested during the recruitment process
• Pfizer is an equal‑opportunity employer and complies with all applicable equal employment opportunity legislation
• Applicants are advised to review Pfizer’s AI‑use guidelines for the recruitment process