Quality Assurance Expert Qualification & Validation of Instruments
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 Qualification & Validation of Equipment and Instruments.
- Establish and maintain Equipment Qualification System at Drug Product Services for both manufacturing equipment and analytical instruments
- Ensure proper qualification of equipment/instruments/computerized-systems and staff by making certain the corresponding VMP(s) and GMP guidelines are being adhered to respectively
- Supervise and execute compliance activities like GMP status, trending of equipment qualification/re-qualification in relation to supplier qualification, changes, non-conformities, CAPAs, audit/inspection/self-inspection observations, document management; vendor change notification; participation in audit/inspection/self-inspection
- Support and supervise proper qualification of equipment suppliers and services by ensuring adherence to quality agreements and audit observations
- Counsel and support various groups within DPS in regards projects and GMP aspects
- Academic degree (Masters 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.