Senior Specialist, Quality SGIE

China, Guangzhou

Today, Lonza is a global leader in life sciences operating across three continents. 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 based 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.

As Senior Specialist, Quality SGIE, you will support day-to-day Quality and Regulatory activities related to Lonza’s Strategic Growth Investments projects in accordance with approved Project Plans and Policies.

Key responsibilities:

  • Support day-to-day Quality SGIE activities in accordance with approved Project Plans and Policies for a fast-paced project.
  • Highly motivated individual and have strong understanding of Commissioning and Qualification (C&Q) of a pharmaceutical plant.
  • Strong Understanding of advanced topics pertaining to C&Q planning and execution.
  • A competent reviewer and approver of Project Design, C&Q plans/ protocols/ summary reports/ discrepancy reports/ GxP SOPs/ records.
  • Member of cross functional project team(s) on quality issues.
  • Coordinate between project groups and departments for multiple parallel activities.
  • Any other tasks as and when assigned by supervisor

Key requirements:

  • Bachelor or above in Quality Management, Engineering or related Science discipline
  • Solid Experience in Regulated pharmaceutical industry including engineering, manufacturing, quality assurance, quality control, R&D and/ or drug regulatory affairs
  • Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP and ICHQ7).
  • Demonstrated track record in completing projects under tight timelines
  • Good interpersonal skills.
  • Effective oral and written communication skills, action orientation, and ability to work well in a cross functional environment.
  • Exhibit good quality decision making traits.
  • Meticulous and Systematic.
  • Analytical Mind.
  • Team player who can operate independently, with strong focus on safety, quality and timelines.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

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: R41729