Quality Operation Specialist
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 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.
As Quality Operation Specialist, you need to support day-to-day Quality Assurance activities in accordance with approved Standard Operation Procedure / Policies for a large scale, multi-product, and Good Manufacture Practices biotech contract manufacturing facility; Generally provide documentation and area knowledge support to staffs; Develop good working relationships with internal customers; A good understanding of Current Good Manufacture Practices and compliance in a Good Manufacture Practices manufacturing setting performing both supervised and unsupervised tasks.
- Monitor day-to-day Quality Assurance activities;
- Highly motivated individual and have skills in all areas relevant to the job;
- Handling deviation and Corrective and Preventive Actions in Trackwise System (TW); Able to assist in deviation investigations and discrepancy reports.
- Batch Record Review per applicable Standard Operation Procedure and Manage the product labeling systems;
- A competent Reviewer of Standard Operation Procedures, protocols, reports or records;
- Demonstrates ability to lead a small project and manage the deliverables effectively;
- Able to develop skill as an internal Current Good Manufacture Practices auditor;
- Ensure that documentation hand over and archiving is completed in accordance with department and company requirements;
- Identify situation which may require escalation to supervisor;
- Provide training and technical advice to other staffs as required;
- Any other tasks as and when assigned by manager.
- Relevant experience and accomplishment to dictate final position for which the candidate may qualify
- Good problem solving and analytical skills
- Good communication skills
- Decision Making
- Effective Communication
- Personal Orientation
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.