QA Officer - BIO Section
Asahi Intecc Hanoi Co., Ltd. · Hanoi
Job description
About the role
The Bio Section QA Officer will lead and supervise daily microbiological activities in our biotechnology laboratory, ensuring all testing complies with regulatory and quality standards.
Key responsibilities
- Perform and supervise daily bio‑lab activities, including bioburden, endotoxin, sterility testing and environmental monitoring.
- Record, review and report test results accurately and within required timelines.
- Prepare, revise and maintain SOPs, test methods and validation documents.
- Ensure all testing follows ISO 13485, internal SOPs and applicable quality requirements.
- Support continuous improvement initiatives within the laboratory.
Required profile
- Male or female, under 40 years of age.
- Bachelor’s degree or higher in Microbiology, Biology, Biotechnology, Biochemistry or a related field.
- 5‑7 years of experience in microbiology or bio‑lab operations, preferably in the medical‑device or pharmaceutical industry.
- Strong practical experience with bioburden, endotoxin, inhibition, Gas Chromatography, sterility testing and environmental monitoring.
- Good knowledge of quality systems and regulatory requirements.
Required skills
- Microbiology
- Biotechnology
- Quality Assurance (QA)
- ISO 13485
- Analytical skills
- Bioburden testing
- Endotoxin testing
- Inhibition testing
- Gas Chromatography
- Sterility testing
- Environmental monitoring
- SOP development
- Validation documentation
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Published 1 month ago
Expires 1 hour from now
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Asahi Intecc Hanoi Co., Ltd.
Hanoi
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