(Senior) Quality Assurance Expert Equipment Qualification & Validation DPS 80-100% (m/f/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.
For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in 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 (Senior) QA Expert Equipment Qualification & Validation DPS (m/f/d) 80-100%
Key responsibilities:
Establish and maintain Equipment Qualification System at Drug Product Services for aseptic manufacturing equipment and infrastructure
Ensure proper qualification of equipment/infrastructure/computerized-systems and staff by making certain the corresponding VMP(s) and GMP guidelines are being adhered to respectively
Supervises compliance activities like GMP status and trending of equipment qualification/re-qualification
Supervises and executes the supplier qualification, GMP-changes, non-conformities, CAPAs, audit/inspection/self-inspection observations, document management; vendor change notification;
Participation in audit/inspection/self-inspection
Ensures the proper qualification of equipment, supplier /services by supervising adherence to quality agreements and audit observations
Counsel and support various groups within DPS in regards projects and GMP aspects
Key requirements:
Academic degree (Bachelor or higher) in Chemistry, Biochemistry, Pharmaceutical Sciences or related field
Significant working experience in pharmaceutical industries and cGMP controlled environment
Significant working experience in qualification of pharmaceutical (aseptic) equipment and the related infrastructure (HVAC, clean media)
Excellent working knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems
Favourable working experience in Quality Assurance
Excellent communication and decision-making skills
Fluency in written and spoken English , basic German skills
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.