Assists the Head of Quality to promote the construction and optimization of GenScript'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 audit
- 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 complains, 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
GenScript USA Inc/ProBio 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./ProBio Inc. maintains a drug-free workplace.
Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.
Top Skills
What We Do
Founded in 2002 and listed on the Hong Kong Stock Exchange in 2015, GenScript has an established global presence across Greater China, North America, the EU, and Asia Pacific. Today, over 300,000 customers from over 160 countries and regions worldwide have used GenScript’s premier, convenient, and reliable products and services. GenScript currently has over 5,000 employees globally, 33% holding master’s and/or Ph.D. degrees. In addition, GenScript has a number of leading commercial technologies developed in the fields of synthetic biology, immunotherapy, antibody design, chemical synthesis, and bioinformatics, including more than 100 patents and over 270 patent applications. As of June 2022, GenScript's products and services have been cited by 74,700 scientific papers worldwide. GenScript is committed to striving toward its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.
