Quality Assurance Expert Analytics, Drug Product Sevrices
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Quality Assurance Expert Analytics.
- Establish and maintain Quality Management System at Lonza Drug Product Services
- Ensure proper qualification of DPS staff and adherence to GMP for stability studies and reference standards
- Review and approve 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
- Make sure all relevant parties adhere to GMP regulations and quality agreements
- Verify compliant qualification of suppliers, material, equipment, instruments (incl. CSV) and validation of methods and processes
- Supervise and execute GMP compliance activities and act as last approver of major deviations for Analytics/Quality Control and OOS investigations
- Counsel different groups on projects and GMP aspects
- 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
- Bioassay / potency testing experience is a plus
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.