Quality System Specialist

Guangzhou, China

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market. You need to execute and maintain Quality Systems at Lonza Guangzhou site by the provision of oversight to day-to-day Quality Assurance activities in accordance with approved Standard Operation Procedure/ Plan / Policies for a multi-product, Current Good Manufacture Practices biotech contract manufacturing facility.

Key responsibilities:

  • Support the start-up of Quality Systems for the site.
  • Execute and maintain the Quality Systems at the site.
  • Document Management System
  • Write, Revise, Review and Approve Standard Operation Procedure, protocols, reports or records.
  • Conduct training
  • Provide guidance on Current Good Manufacture Practices, Good Documentation Practices and Data Integrity requirements.
  • Training/Learning Management System
  • Maintenance of training curriculum/tasks.
  • Custodian and archival of training records.
  • Provide guidance on Learning Management System usage.
  • Trackwise System
  • Provide guidance on deviation management, change control and Corrective And Preventive Actions
  • Conduct training and provide guidance on trackwise system usage.
  • Communicate quality systems and compliance requirements effectively to peers and stakeholders.
  • Provide compliance support to staff in all departments.
  • Participate in regulatory, customer and internal audits.
  • Any other tasks as and when assigned by the supervisor/line manager.

Key requirements:

  • Familiarity with Regulatory requirements and local Codes & Standards (e. g. , Food and Drug Administration, European Agency for the Evaluation of Medicinal, Good Automated Manufacturing Practice and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
  • Good knowledge and experience of the practical and theoretical requirement of validation program in Good Manufacture Practices facility
  • Good leadership skills
  • Strong interpersonal skills
  • Effective Communicator (oral and written)
  • Exhibit good quality decision making traits
  • Meticulous and Systematic
  • Analytical Mind
  • Ability to define specific goals clearly, to develop and prioritize activities
  • Team player, with strong focus on safety, quality and timelines

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R21177