Senior QA Specialist - Project Manager (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.
The role:
For our Quality Assurance team in Bioconjugates we are currently looking for a dedicated person who would like to work as a Senior QA Specialist, and Project Manager (f/m/d) in a fast-growing and innovative environment. The person will support clinical phase manufacturing and will interact with internal and external stakeholders to represent Quality.
Key responsibilities:
As a member of the quality assurance team (Bioconjugates), you will be responsible for ensuring production of API`s is in accordance with Good Manufacturing Practice (GMP).
Support the contract manufacturing and advise members of development, production, and analytical departments on all aspects of GMP.
Responsible for checking manufacturing documentation for conformity, processing change controls, and reviewing and approving deviations and OOS results.
In addition, you will be the quality contact for our clients, and will present during their GMP audits.
Key requirements:
Bachelor's or Master's Degree in Life Science (microbiology, biotechnology, chemistry).
At least 2 years of experience in the biopharmaceutical industry, ideally in the GMP area, is preferable.
Strong communication skills, and experience in working with stakeholders from different departments.
Experience with TrackWise, SAP, LIMS, and DMS is a plus.
Fluency in English (writing and speaking) is required for stakeholder communication, and German skills on the C1 level are required to interact with colleagues on a daily basis.
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.