Job Description

About GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript\'s businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnologyAbout GenScript ProBioGenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. GenScript ProBio\'s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, GenScript ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, GenScript ProBio has a stable and high-yield viral vector platform.Job Scope:Assist the QA Manager to promote the construction and optimization of the GenScript (Singapore) Quality System and to promote the implementation of on-site quality management requirements to ensure the continued effectiveness of the quality system.

• Identify on-site problems/potential problems in a timely manner through daily supervision, and ensure timely rectification of the problems/potential problems through communication and coordination to improve on-site quality management
• Participating in the investigation and handling of product complaints, returns and non-conforming products and materials
• Participating the management and optimization of the company quality documentation, materials, suppliers, changes and CAPA systems
• Responsible for quality training
• Responsible for organizing internal and external quality system audits GenScript (Singapore)
• Any other QA related tasks assigned by line manager

Job Requirements:

• Bachelor\'s degree in Biology, Chemistry, Pharmacy, Medicine and related disciplines
• 3 or more years of work experience in ISO9001 system management and/or QA site management
• Proficiency in ISO 9001 quality system requirements
• Expertise in biology and chemistry
• Excellent communication and coordination skills, strong analytical and problem-solving skills
• Bilingual (English and Chinese) is an advantage

This role would be fully onsite.Location: Solaris @Kallang 164, East Wing building, Singapore 349248#GS#LI-CT1GenScript USA Inc/GenScript ProBio USA Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company\'s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.GenScript USA Inc./GenScript ProBio USA Inc. maintains a drug-free workplace.

GenScript