QA Expert Qualification & Validation of Equipment and Instruments, Drug Product Services
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 DPS (Drug Product Services) in Basel, we have an open position for a QA Expert Qualification & Validation of Equipment and Instruments.
- Executes establishment and maintenance of Equipment Qualification System at DPS for both manufacturing equipment and analytical instruments
- Supports both DPS sites: Basel and Stein
- Ensures the proper qualification of equipment/instruments/computerized-systems by ensuring adherence to the corresponding VMP(s)
- Supervises and executes compliance activities like GMP status and 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
- Ensures the proper qualification of DPS staff by supervising adherence to GMP trainings
- Ensures the proper qualification of equipment supplier /services by supervising adherence to quality agreements and audit observations
- Counsels and supports the groups in DPS in projects and GMP aspects.
- Performs other duties as assigned.
- Academic degree in Engineering, Pharmaceutical Technology, Natural Science or related fields
- Experience in Pharmaceutical Industries and GMP controlled environment, preferable in Quality control, Production or Quality Assurance
- Extended experience from participation in audits and authorities inspections
- Extended knowledge in EU and US, GMP regulations relevant for equipment qualification, maintenance and corresponding compliance systems
- Extended knowledge in EU and US, GMP regulations relevant for computerized systems validation
- Excellent ability to provide solutions for complex challenges
- Excellent communication and Decision-making skills
- Language: Excellent command of English, second language German necessary
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.