R40291 QA Manager Cleaning Validation (f/m/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.
Ibex® Solutions (www.ibex.lonza.com) is a modular build complex to develop and manufacture biological products. It enables companies to get access to a complete solution, gaining speed and achieving a simplified value chain. The Ibex® Complex is our contribution to the medicine of tomorrow and possibly the next step in your career? Start your career with Lonza today. Apply as QA Manager Cleaning Validation (f/m/d)! The QA Manager Cleaning Validation operates in close cooperation with the production department and ensures that all cleaning processes for manufacturing equipment throughout their lifecycle are performed and validated in compliance with cGMP requirements and internal/external quality standards.
As a Quality and Compliance representative, he/she will be a key member in cross-functional technical project teams.
Defines and owns the process specific Cleaning Validation strategy
Coordinates Quality and Compliance objectives during the different project phases with regards to the Cleaning Validation
Supports and approves Quality Risk Analysis related to equipment cleaning (e.g. FMEA)
Preparation of periodic reports related to the cleaning lifecycle (Annual Cleaning Review)
Supports specific projects in cleaning validation area of expertise to develop further the quality standard
Enhances the quality knowledge by following the quality standards and by visiting specific training courses/conferences
Bachelor, Master Degree or PhD in Biotechnology, Pharmacy, Microbiology, Chemistry, Engineering, or related field
More than 5 years of experience in the area of biopharmaceutical manufacturing, preferably in a qualification/validation function as well as strong background in cGMPs
Broad knowledge of engineering and manufacturing processes
Good communication skills and interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
Fluency in English, German would be an advantage
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.