Quality Assurance Expert QC Analytics
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.
For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have an exciting opportunity. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and be responsible to provide quality oversight to commercial testing activities by applying for the position as Quality Assurance Expert Analytics.
Executes establishment and maintenance of the Quality Management System at DPS QC commercial
Ensure proper qualification of DPS Commercial Quality Control staff and adherence to GMP for stability studies and reference standards
Review and act as last approver of methods, qualification/validation/transfer protocols and reports as well as analytic related SOPs
Act as fist contact concerning compliance issues for local and shared systems (e.g. LIMS) including approval of specifications in LIMS
In charge of release and rejection of analytical testing in delegation of technically responsible person (FvP)
Provide raw data review and quality assurance oversight for commercial testing activities
Supervise and execute GMP compliance activities and act as last approver of major deviations for Analytics/Quality Control and OOS investigations
Participate in and support audits and inspections
Academic degree (Master or higher) in Chemistry, Biochemistry, Pharmaceutical Sciences or related field
Significant working experience in Quality Assurance in pharmaceutical industries and cGMP controlled environment
Good working knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems
Sound knowledge in testing of biological drug products
Excellent communication and decision-making skills
Ability to work independently in a team environment
Excellent knowledge of written and spoken English
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.