Senior QA Specialist
United Kingdom, Slough
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 have a great opportunity for a Senior QA Specialist to join our QA Technical Support Team based in Slough, UK.
As a Senior QA Specialist, you will enable site operations performance by managing and supporting GMP issues through QMS processes, site governance mechanisms and senior QA leadership. You will ensure site operations compliance by acting as a cGMP SME and by designing, implementing, managing, and enforcing quality processes on site to encourage a ""quality at point of doing" culture.
- Provide shoulder to shoulder review, approval and QA technical support to key business partners for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations
- Manage and escalate Major and Critical compliance issues through the site QMS processes
- Actively identify, suggest and participate in continuous improvement activities
- Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment
- Maintain and promote a state of audit readiness
- Actively suggest, initiate, participate and contribute to PQS process improvements initiatives and projects
- Provide QA SME support at departmental Local Quality Councils and project meetings
What we need you to have:
- BSc in Science or QA discipline
- Significant on the job work experience in a GXP environment
- Excellent communication skills (verbal and written)
- Excellent risk based decision-making and problem solving skills
- Previous QMS process design, implementation, management and utilisation experience
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.