Job Detail
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Offerd Salary (USD) Login to view salary
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Career Level Team leader/ Supervisor
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Experience 3-5 Years
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Gender Male/Female
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Sector Hanoi, Hai Phong, Hai Duong
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Industry Health Care/Medical Equipment, Pharmaceutical/Biotech, QA/QC
Job Description
Dream Job Alert! Become a Vice Quality Manager (Medical devices/Pharma, ID19669) at a foreign-invested company and earn $1700/month:
- Assist in establishing, implementing, and maintaining the Quality Management System (QMS) in compliance with GMP and applicable ISO standards (ISO 13485 / ISO 13484).
- Ensure all manufacturing and production activities comply with regulatory requirements and internal quality standards for medical devices.
- Participate in the preparation, implementation, review, and continuous improvement of SOPs, quality manuals, and related quality documentation.
- Manage and oversee ISO Class 8 cleanroom operations in accordance with GMP and regulatory requirements.
- Ensure strict adherence to cleanroom standards, including environmental monitoring, hygiene practices, and contamination control.
- Supervise validation, qualification, and routine monitoring of cleanroom facilities, systems, and equipment.
- Support and participate in internal audits, external audits, and inspections conducted by regulatory authorities and certification bodies.
- Prepare audit documentation and reports, manage corrective and preventive actions (CAPA), and ensure timely closure of identified non-conformities.
- Deliver GMP, ISO, and cleanroom compliance training to production and quality personnel.
- Support the Quality Manager in supervising quality staff and coordinating quality-related activities across departments.
Requirement
- Male or female, under 45 years old.
- University degree in Pharmacy (licensed pharmacists are preferred).
- 3–5 years of experience in the position of Quality Manager or Deputy Manager in the medical device or pharmaceutical manufacturing industry.
- Proficient in English.
- Direct experience working with customers and managing cleanroom operations in compliance with GMP quality standards; ISO Class 8 cleanroom experience is highly preferred.
Keywords
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