Qa manager

7 days ago

Singapore Initial Therapeutics, Inc. Full time

About Gen Script
Gen Script Biotech Corporation (Stock Code: 1548. HK) is a global biotechnology group. Founded in 2002, Gen Script has an established global presence across North America, Europe, the Greater China, and Asia Pacific. Gen Script'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.
Gen Script is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.
About Pro Bio
Pro Bio proactively provides 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. Pro Bio’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, Pro Bio supports the most clinical approvals for CGT drugs including m RNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for m RNA vaccines and has supported several m RNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, Pro Bio has a stable and high-yield viral vector platform.
Assists the Head of Quality to promote the construction and optimization of Gen Script's (Singapore) Quality System, and to promote the implementation of on-site quality management requirements to ensure the continued effectiveness of the quality system.
Key Responsibilities:
Promote the maintenance and continuous improvement of the quality management system
Responsible for the management and optimization of the quality documentation, materials, suppliers, changes and CAPA system
Responsible for organizing internal and external quality system audits
Identify on-site problems/potential problems in a timely manner through daily supervision, and ensure timely rectification through communication and coordination to improve on-site quality management
Participate in the investigation and handling of product complaints, 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 effectively bi-lingual in English and Mandarin as this role requires close collaboration with stakeholders and counterparts in China
Gen Script USA Inc/Pro Bio 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.
Gen Script USA Inc./Pro Bio Inc. maintains a drug-free workplace.
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