Pharma Labelling Compliance Expert
Vor 5 Tagen
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 labeling compliance at Lonza Visp. Accountable for combining scientific, regulatory and business requirements to ensure compliance with safety and regulatory in line with global Lonza standards. Process owner and responsible for monitoring and interpreting changes in global regulations. Demonstrates high understanding of applicable international standards and global regulations in collaboration with the “Operational Labeling expert, Visp” guide and communicates across multiple collaborators within Lonza.
Role / Main Responsibilities:
- Ensures that all product labels at the Visp site align with relevant regulatory requirements, including FDA regulations, EU directives, and other applicable standards in different regions.
- Work in close collaboration with Product Safety and EHS teams.
- Accountable for adhering to ADR, ICH, GHS, and CLP standards for chemicals and pharmaceutical labeling.
- Identify potential risks related to regulatory changes and implement strong strategies to minimize risks of customer & legal complaints as well as financial impacts on our business.
- Provide mentorship and training to staff and collaborators on labeling regulations, processes, and standard methodologies.
- Monitor and anticipate evolving regulatory requirements.
- Identify and ensure appropriate responses or adaptations.
- Accountable for the timely availability of all product labels in Visp to ensure business continuity of small molecules and biologics operations.
- Candidates should have a University degree in Chemistry/Biology or Life Sciences, or possess equivalent experience of at least several years.
- Advanced work experience in Manufacturing, Product Safety, Chemistry, GMP, and Classification.
- Assertiveness in interacting with different functions and the ability to work with diverse teams.
- Relocation assistance available for candidates applying inside of the EU
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.
Reference: R64086
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