QA Manager - Abbott Pharmaceutical
On-siteHo Chi Minh City, Ho Chi Minh City (HCMC), Vietnam
Job Summary
Manage daily quality operations for the FIE warehouse in compliance with GSP, GDP, and Abbott standards. Review batch documentation to support product release and rejection decisions, coordinate product investigations, and maintain quality records for data integrity. Initiate and track change controls, manage deviations and nonconformances, and lead root cause analysis for corrective actions. Receive and assess product quality complaints, perform trending analysis, and ensure documentation closure within timelines. Conduct internal audits, Gemba inspections, and prepare inspection readiness for regulatory audits and GSP re-certification. Coordinate responses to inspection observations and track CAPA implementation with local health authorities.
Required Qualifications
- At least 4 years' experience in Pharmaceutical or medical device
- Pharmacist with at least 4 years' experience in Pharmaceutical or medical device (or related industry)
- QA/Regulatory Experience with FIE warehouse or QA manufacturing site
- Bachelor - At least bachelor's degree of Medical/ Pharmacy
- Adaptability
- Initiative
- Integrity
- Planning and Organizing
- Ability to prioritize
- Ability to use Quality Tools and Quality IT systems such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact base decisions making
- DARIUS
- ISOtrain
- SolTRAQs
- Project management and troubleshooting skills
- Ability to communicate both written and orally, to all levels of management and across different cultural backgrounds
- Ability to identify problems and initiate corrective actions and preventative actions
- Sound decision-making skills contributing to high levels of competence, confidence and credibility
- Well-developed interpersonal, communication and negotiation skills
- Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.)
- Change management
- Strong regulatory and GxP compliance
- Language Skill Vietnamese/ Tiếng Việt
- English/Tiếng Anh
- Computer Skill MS Office Online activities (Meeting, QA IT Systems)
- Ability to use Quality Tools and Quality IT systems such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact base decisions making
- DARIUS
- ISOtrain
- SolTRAQs
- Project management and troubleshooting skills
- Ability to communicate both written and orally, to all levels of management and across different cultural backgrounds
- Ability to identify problems and initiate corrective actions and preventative actions
- Sound decision-making skills contributing to high levels of competence, confidence and credibility
- Well-developed interpersonal, communication and negotiation skills
- Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.)
- Change management
- Strong regulatory and GxP compliance
- Language Skill Vietnamese/ Tiếng Việt
- English/Tiếng Anh
- Computer Skill MS Office Online activities (Meeting, QA IT Systems)
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