Associate QA Manager

2 weeks ago


Hanoi, Vietnam Abbott Laboratories Full time

**Primary Function**:

- Primary point of contact for all QA matters related to VN Core Dx Representative Office.
- Responsible for VN Core Dx Commercial Affiliates in all GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) Quality activities.
- Provide expertise to the VN Commercial Affiliates to Improve and maintain the quality system.
- Accountable for Post Market activities in VN including complaint related tasks Recalls, Field Action communication and activities including Recalls, Advisory Notices etc and participate in the execution of required customer communications.

**Responsibilities/ Objectives**:

- Ensure that the Quality management system is established, implemented, maintained, controlled and recorded in compliance with the International and local regulations and Abbott policies and procedures.
- Support Country Management to ensure compliance with procedures, policies and legal requirements.
- Implement periodic management review of quality system with country management and report to area
- Handle the QH/FA/PI/Recall documents as per relevant procedures.
- Assure all equipment used for service operation are properly calibrated and maintained.
- Evaluation, management of Distributors including working with them on the SCARs ( Supplier Corrective Action Records)
- Evaluation, management of Suppliers including working with them on the SCARs ( Supplier Corrective Action Records)
- Primary contact for all external and internal audits, ensure that all findings and related CAPAs are documented and executed per the OACA procedures.
- Meeting with internal and external stakeholders, Regional and Global teams and other projects.

**Education**:

- Degree graduate in college course in Chemistry, Microbiology, Pharmacy, Engineering or Science related discipline.

**Background and Experiences**:

- >5 years experience in a Quality role in Medical Device or Pharmaceutical industry
- ISO 13485 and GMP knowledge
- Good communication and negotiation skill to facilitate implementation of complex technical solutions and must possess independent decision making skills.
- Quality Auditor Certification



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