Deviation Manager 80-100% (f/m/d)
Today Lonza is a global leader in life sciences. 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.
Ibex® Solutions (www.ibex.lonza.com) is a modular build complex to develop and manufacture biological products. It enables companies to get access to a complete solution, gaining speed and achieving a simplified value chain.
The Ibex® Complex is our contribution to the medicine of tomorrow and possibly the next step in your career? Start your career with Lonza today. Apply as Deviation Manager.
You will represent Operations, over taking ownership of Deviations in project/tech transfer organizations for new biotech manufacturing processes and cooperate closely with QA in defining solutions.
Responsible to author, record and investigate Deviations, Change Requests, Effectiveness Checks
Performs assessments for all product-related changes, assesses relevance to regulatory filings, decides to implement and provide change controls for approval to customers where required.
Supports and approves project/product specific risk assessments.
Performs internal and external audits.
Responsible to drive CAPA and effectiveness check items to completion and timely closing
Ensures an efficient cGMP compliant life cycle management of all products manufactured.
Bachelor degree or equivalent
Previous experience in Deviations, GDP and GMP regulated pharmaceutical / API industry is an advantage
Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
English very proficient, German will 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.