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.
