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 Lonza, Ibex® Solutions (https://www.lonza.com/), our unique biological manufacturing and development concept in Visp, Switzerland, we are searching for a team member. Become part of this exciting opportunity and join our team by applying for the position as Senior QA Specialist for our Buffer Manufacturing plant.
Key responsibilities:
Review and approval of manufacturing recipes, deviation records and change requests
Supporting the definition of preventive and corrective measures (CAPAs), approving them and tracking their timely implementation and effectiveness
Review and approval of SOPs and project related documents, as well as supporting and approving quality risk analysis (e.g. FMEA)
Writing and revising the SOPs in own area of responsibility
Facilitating discussions within internal cross-functional teams such as MSAT, Manufacturing and QC
Supporting cGMP training programs to ensure staff is trained
Being involved in customer audits as well as in regulatory inspections and supporting all activities to ensure inspection readiness of the department
Actively supporting the Quality culture as a role model
Performing other duties as assigned
Key requirements:
Bachelor or Master degree in a relevant scientific discipline
Significant experience in Quality Assurance within the Bio / Pharma industry, with strong knowledge of cGMP requirements
Experience in batch disposition activities
Working knowledge in TrackWise, DMS, SAP and LIMS systems
Fluency in English. Ability to communicate or willing to learn German
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.