Senior QA Specialist- External Quality
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.
We are currently looking for an experienced Senior Quality Specialist to be join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.
Reporting to the External Quality Manager or Sr. Team Lead External Quality. The brief will focus on leading, managing and overseeing customer projects and acting as the point of contact for general queries relating to QA from customers and project teams. Be the Lonza QA face to customers.
Represent Lonza as QA representative on customer project teams. Support regulatory inspections and customer audits. Supporting senior QA leadership and QP decision making to drive continuous improvement and ‘’fit for purpose’’.
- Acting as a point of contact for general queries relating to QA from customers and project teams.
- Draft, negotiate and complete quality agreements with customers.
- Act pro-actively towards external and internal customers
- Regulatory Inspections and customer audits support: Support and host regulatory inspections and customer audits.
- Manage any outcomes/findings, ensure appropriate responses and escalate if necessary
- Support QP and QA management as required.
- Provide QA support to initiate, participate and contribute to PQS process improvements initiatives and projects.
- Apply GMP regulations consistently and use knowledge of GMP and quality processes to actively identify, suggest and participate in continuous improvement activities.
- Complete all core GMP and relevant training and maintain own training file.
- Identify opportunities for GMP compliance training and awareness campaigns – design, develop and deliver.
- Mentor others to expand on-site compliance knowledge.
- Manage Quality records pro-actively and according to the defined timeframe
What we need you to have:
- BSc in Life Sciences
- Experience working within a GMP-regulated pharmaceutical – ideally biologics or biopharmaceutical – environments and/or relevant QA experience
- Seeks to understand the corporate strategy and how his/her business area
- Contributes to the company’s success
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.