QA Manager Qualification (f/m/d) (80-100%)
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.
Become part of an exciting opportunity and join our team by applying for the position as QA Qualification Manager. In this role, you own all quality related responsibilities for the daily qualification activities of new facilities, equipment, utilities and systems related to the cGMP manufacture of pharmaceutical products.
Representative of QA Qualification in the project organization for new facilities or other projects in regards to qualification of facilities, utilities, equipment and systems
Coordinating different QA interests during the project phase e.g. process, cleaning or other relevant QA objectives
Driving implementation of new qualification strategy and being a strong decision maker when needed
Compiling, reviewing and releasing Qualification Documents (URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports and more) as also supporting and approving quality risk analysis (e.g. FMEA)
Performing assessments and approvals of technical changes requests during the different phases of a project and lifecycle and their relevance to the qualification of facilities, equipment, utilities and systems
Representing qualification topics during customer audits and regulatory inspections
Being responsible to drive CAPA and Effectiveness Checks items to completion and timely closing as well ensuring deviations are appropriately investigated and recorded in Deviation Reports
Bachelor or Master degree in Engineering, Chemistry, Biotechnology or a related field
Significant experience in the pharmaceutical industry, ideally in a QA role would be an advantage
Good understanding of the applicable cGMP regulations
General knowledge of engineering and manufacturing processes
Ability to oversee project execution to identify non-compliance from quality standards
Fluency in German, very good knowledge of the English language
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.