QA Audit Specialist
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 Participate in the establishment and maintenance a robustness and cGMP compliance Quality Audit Systems.
- Implement and maintain Internal Audit Program
- Follow up external regulatory inspections, Customers’ Quality Compliance audits
- Follow up Lonza Global Quality assessments of Quality Management Systems
- Able to direct appropriate follow-up actions on any compliance issues.
- Excellent knowledge and adherence to all relevant codes, standards and regulatory requirements
- Able to develop skill as an internal Good Manufacture Practices auditor.
- Perform the gap analysis between Quality Management Systems & regulatory requirements
- Ensure that documentation hand over and archiving is completed in accordance with department and company requirements.
- Identify situation which may require escalation to supervisor;
- Any other tasks as and when assigned by manager/ supervisor.
- 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
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.