Job Opportunities in Switzerland
September 5, 2024
Lonza
Visp
OTHER
Regulatory Labeling Expert Pharmaceutical (f/d/m)
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.
Responsible for Lonza Visp labeling function, combining knowledge of scientific, regulatory and business issues to ensure compliance with safety and regulatory requirements and Lonza standards. Plans and executes review of safety / non-safety related labeling changes. Demonstrates thorough understanding of applicable international standards and global regulations, communicating across stakeholders. Proactively identifies labeling issues, offering creative solutions and strategies.
Key responsibilities:
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.
Responsible for Lonza Visp labeling function, combining knowledge of scientific, regulatory and business issues to ensure compliance with safety and regulatory requirements and Lonza standards. Plans and executes review of safety / non-safety related labeling changes. Demonstrates thorough understanding of applicable international standards and global regulations, communicating across stakeholders. Proactively identifies labeling issues, offering creative solutions and strategies.
Key responsibilities:
- Develop strategy and oversight process of labeling for CH portfolio.
- Proactively lead the development, strategic optimization, revision, approval and maintenance of labeling documents via close scrutiny of company data, business strategies and regulatory precedents.
- Develop workflows for internal /external partners in the labeling process
- Support all kinds of product label requirements (incl. outside of the SAP GLM e.g. Supply Chain, warehouses, and toll manufacturer).
- Ensure timely availability of labels for the site, by checking all data is in order in SAP, checking, and releasing of labels in SAP GLM.
- Support Master Data Management for labels either within SAP (and related team) or if not possible other systems.
- Maintain required master data in SAP and associate products with existing Label Template.
- Liaison with Operations, Program Management, Supply Chain, Quality, Engineering, IT and Regulatory teams to ensure a compliant, lean and cross-functional approach access to labelling.
- Provide guidance for new products to ensure compliance.
- Bachelor’s or Master’s Degree in the areas Chemistry, Regulatory or similar
- Working experience in Manufacturing and Supply Chain
- Working experience with GMP
- First experience with SAP desirable
- Fluent English and German required
- Assertiveness in interacting with different functions and leadership
- Team player and leader able to be working with divers teams globally
- Passion and endurance to challenge processes and overcome hurdles in the labeling environment
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.
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