Senior QA Specialist – Quality Systems
UK - SloughToday 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.
We have an exciting opportunity for a Senior QA Specialist to provide QA ownership and oversight of the Lonza Slough Pharmaceutical Quality System (PQS) and enable site operations performance by managing and supporting GMP issues through the Pharmaceutical Quality System and site governance mechanisms and supporting Senior QA leadership to drive continuous improvement and ‘fitness for purpose’.
- Ensure PQS is designed to meet Regulatory, Customer and GROUP requirements and is effectively implemented on site
- Utilise knowledge of GMP and quality processes to actively identify, suggest, participate in and manage continuous improvement to ensure that PQS remains effective, efficient, simple and compliant
- Maintain Schedules to ensure schedule adherence for GMP Documentation issuing. Monitor and Reinforce compliance to all cGMPs.
- Monitor and interpret quality metrics and ongoing quality trends to provide information to the site to ensure action is taken in a timely manner to address trends, issue highlighted etc
- Actively develop, mentor, train and enforce a site GMP culture within Operations
- Support regulatory and customer audits of the Operations areas and processes
- Identify opportunities for GMP compliance training and awareness campaigns – design, develop and deliver
- Perform other duties as assigned.
- BSc in Science discipline
- Qualification in Quality would be an advantage
- Significant industry experience within quality and QA
- Significant experience in the design, implementation and ongoing management of Pharmaceutical Quality Management Systems
- Experience of working on and / or run continuous improvement projects on a company wide basis would be an advantage
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.