QA Manager (Pharmaceutical Industry)

POSITION: QA MANAGER (Pharmaceutical Industry)
- Working location: Tan Tao 2 Industrial Park, Binh Tan Dist, HCMC (Warehouse)
- Manage team: 6 members
- Report to: Quality Director
- Offer Shuttle bus (From District 2 / Binh Thanh / District 1 to Warehouse)
1. Purpose of Position
• Ensure adherence to quality standards, policies, and regulations required by the Company, Regional QA guidelines, and prevailing laws.
• Manage the execution and continuous improvement of the company's Quality Management System (QMS).
• Oversee regulatory compliance, internal and external audits, change control, and document control.
• Execute QMS related to Document Management Practices, Quality training programs, audits, supplier qualification, product recall management, customer complaint management, and KPI reporting.
2. Responsibilities:
A. Quality Standards and Policy
• Ensure compliance with quality standards and policies required by Principals, government agencies, international bodies, and regional ZP.
• Coordinate and instruct departments on implementing quality standards and policies.
• Report quality issues to the Director, Projects, and Quality.
• Contribute to the improvement of the company quality system.
• Implement changes to the company quality policy.
B. Quality System and Procedures
• Coordinate product recall processes as requested by PRN or MOH.
• Ensure approved procedures are properly published at designated locations.
• Manage change control and evaluation for all locations.
• Manage controlled documents.
C. Quality Audits
• Prepare GSP dossier for MOH submission regularly.
• Coordinate with internal teams to welcome external audit teams and follow up on actions needed.
• Plan and conduct internal audits at defined intervals.
• Report audit results promptly and regularly.
• Monitor CAPA results of the entire QMS.
D. Management for Quality Complaint and Pharmacovigilance
• Manage customer complaints related to quality and ensure timely responses.
• Investigate root causes of quality complaints and develop CAPA.
• Monitor complaint turnaround time to ensure KPI achievement.
E. Other Quality Management Responsibilities
• Set up and coordinate QMS training plans with HR and Quality Managers.
• Manage deviation and incident control, change control, product recall follow-up, risk management, and tasks related to CTM Medical Devices & Diagnostics.
• Review agreements (QAA & PVA).
• Perform other tasks as assigned by the Quality Director.