QA Manager (Pharmaceutical Industry)

POSITION: QA MANAGER (Pharmaceutical Industry)

- Working location: Tan Tao 2 Industrial Park, Binh Tan Dist, HCMC

- Report to: Quality Director

- Offer Shuttle Bus

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.

• Pharmacist degree, Bachelor degree in Biology/Chemistry is preferred

• At least 2 years as a QA Manager with significant achievements

• Experience related to SAP, WMS, cGMP, GSDP, ISO 9001, ISO 13485

• Prior experience in QA for medical devices, pharmaceuticals, or healthcare preferred

• Experience in logistics is an advantage

• Proficient in Excel, Word, and presentation tools; strong presentation skills

• Well-developed risk analytical and problem-solving skills

• Complexity management skills

• Planning and organizational skills

• Open and independent mindset, good listener, and team player

• Detail-oriented, accurate, and trustworthy

• Persistent and industrious

• Able to work in a fast-paced and deadline-driven environment