
Highly Skilled Quality Assurance Expert Wanted
2 weeks ago
About GenScript:
We are a global biotechnology group with an established presence across North America, Europe, the Greater China, and Asia Pacific.
Our businesses encompass four major categories based on our leading gene synthesis technology:
- CRO services for life sciences
- Enzyme and synthetic biology products
- Biologics development and manufacturing
- Cell therapy solutions
We strive to be the most reliable biotech company in the world, making humans and nature healthier through biotechnology.
About ProBio:
We provide end-to-end CDMO services from drug discovery to commercialization with proactive strategies, professional solutions, and efficient processes in cell and gene therapy, vaccine, biologics discovery, and antibody protein drug development.
We offer total cell and gene therapy solutions covering CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.
Key Responsibilities:
- Promote the maintenance and continuous improvement of the quality management system
- Manage and optimize quality documentation, materials, suppliers, changes, and CAPA systems
- Organize internal and external quality system audits
- Identify and address on-site problems/potential problems through daily supervision and communication
- Participate in product complaint investigations and handle returns and non-conforming products and materials
- Responsible for quality training
Requirements:
- Bachelor's degree in science or engineering
- Minimum 5 years of experience in ISO9001 system management, QA site management
- Experience in setting up QMS systems is preferred
- Knowledge and experience in ISO 9001 quality system requirements and certification process
- Experience working in the pharmaceutical manufacturing/biotechnology industry is preferred
- Excellent communication skills and bilingual ability in English and Mandarin
Benefits:
- Proud equal opportunity/affirmative action employer committed to diversity and inclusion
- Employment opportunities without discrimination or harassment
Others:
We maintain a drug-free workplace and only contact candidates through verified application sources. We do not request personal information from candidates through individual email or any other platform.
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