QA Manager

3 weeks ago

Singapur, Singapore BioSpace Full time

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group founded in 2002, with a global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript’s businesses include four major categories based on its gene synthesis technology: life science CRO operations, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy. GenScript aims to be the most reliable biotech company in the world to make humans and nature healthier through biotechnology.

About ProBio

ProBio proactively provides 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 to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical and commercial manufacturing.

Role overview

Assists the Head of Quality to promote the construction and optimization of GenScript's (Singapore) Quality System, and to implement 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 quality documentation, materials, suppliers, changes, and CAPA system
  • Organize internal and external quality system audits
  • Identify on-site problems/potential problems 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 and 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 bilingual in English and Mandarin as this role requires close collaboration with stakeholders and counterparts in China

GenScript USA Inc./ProBio Inc. is an equal opportunity/affirmative action employer committed to 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, 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.

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