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.
Currently we are looking for a (Senior) QA Specialist / Expert Compliance who will support to establish and maintain quality management & compliance processes at our site in Stein. The initial focus of this position will be focus on the development and continuous improvement of the document management system (DMS). The other parts of the Pharmaceutical Quality System (PQS) (deviation & CAPA Management, Change Control) and inspection readiness will also be part of the responsibility of this position at a later date.
Apply for this interesting opportunity and build-up our compliance organization within our growing Drug Product Services organization!
Key responsibilities:
- Supporting the establishment / implementation and maintenance of the Quality Management System at Stein
- Responsibility to maintain CAPA management processes as a local process owner including relevant SOP’s, training materials, work instructions and user’s training / qualification
- Responsibility to provide QA support and oversight for archiving process for Stein site
- Responsibility to maintain document management system including relevant SOP’s, training materials, work instructions and user’s training / qualification
- Execution and support of GMP compliance activities, e.g. deviation and change management, audit support and inspection management support
Key requirements:
- Bachelor or Master degree in life sciences or pharmacy degree
- Working experience in Quality Assurance in pharmaceutical industries and GMP environment preferable in sterile manufacturing (e.g. QA oversight, QA operations)
- Significant experience with Quality Management System (deviation & CAPA management, change control) , as well as experience in the usage of e.g. Trackwise / Veeva are highly desired
- Experience in the archiving process and with matrix organization would be advantageous
- Experience in aseptic drug product, fill-finish or sterile manufacturing would be advantageous
- English (spoken and written), German skills are advantageous
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.
What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
