Quality Assurance (QA) Officer
United Kingdom, Livingston
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 is 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.
Reporting to the QA Manager, this role is responsible for providing wide-ranging support to the QA Department. The ideal candidate will therefore have a background in Quality Assurance including GMP, auditing, document review and approval, participation in a pharmaceutical quality management system and in document management with specific focus on commercial and clinical manufacturing of medical products.
- Support to the site Quality Management System including routine review and approval of change controls, deviations, action plans and audit CAPA
- Review and approval of SOPs.
- Review, approval and issue of manufacturing documentation.
- Participation in root cause analysis investigations arising from deviations
- Support both internal and external audits including writing reports, agreeing CAPA and following these up as required
- Participation in desk-based audits in support of the supplier assessment program
- Review and approval of risk assessments and validation documentation as required
- Conducting in Product Quality Reviews as required
- Coordinating of customer product quality complaints received at site
- Experience of working in a similar Quality role
- Experience of document review and control.
- Able to communicate effectively with people at all levels in a Company.
- Able to write clear, concise reports.
- Working within a GMP environment, ideally within a manufacturing facility
- Audit experience (internal and supplier auditing)
- Experience in participating in site Regulatory Inspections, MHRA/FDA
- A degree or equivalent in Chemistry, Pharmacy, Biology or general science.
- A knowledge of Trackwise® or similar quality management software
- A knowledge of SAP® or other ERP system
- A knowledge of Documentum® or similar document management software
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.