Today, Lonza is a global leader in life sciences operating across three continents. 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.

As Senior QA Specialist Microbial you are owning all quality related responsibilities for the daily activities of API manufacturing processes for large scale production. Being one of the main stakeholder for quality assurance in production, you are working together with others in a middle sized team on projects.

Key responsibilities

• Responsibility for batch releases and accountability for the quality of all related records (Deviation, changes, investigation, CAPA)

• QA oversight for the dedicated manufacturing project

• Single point of contact for the coordination of quality-related topics with customers

• Make quality decisions for dedicated projects in internal and external meetings

• SME for clients audits and participate in regulatory inspections of health authorities

• Support and initiation of continuous Improvement projects and activities

• Compiling, verifying and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Testing Protocols & Reports etc.

Key requirements:

• Master Degree in natural sciences (e.g. Biology, Biotechnology), or Bachelor degree with substantial work experience

• Significant work experience in a GMP related pharmaceutical environment; preferable within a Quality unit

• Experience handling / managing stakeholder on different levels

• Knowledge in the usage of LIMS and TrackWise would be an advantage

• Fluent language skills (written and oral) in English, German skills are preferred as addition

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.