Senior Batch Record Reviewer (f/m/d)
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.
In Visp we are looking for a Senior Batch Record Review IBEX™ to extend our team. You will report to the Operations Group Leader IBEX™, work in close collaboration with different quality and operations functions in order to ensure cGMP-compliant manufacturing activities and documentation within IBEX™.
Review of the Executed Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures, raw data, logbooks)
Support batch release by ensuring the completeness of the documentation package
Review comments added to the Executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
Support the initiation of deviations and investigations for Batch Record review related observations
Collect and evaluate on a regular basis KPI data
Write and revise SOPs in his/her area of expertise
Bachelor degree or equivalent
Previous experience in GDP and GMP regulated pharmaceutical / API industry is an advantage
Ability to identify non-compliance and gaps from quality standards
Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
German native/very proficient and English good command are required
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.