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.
The Supplier & Material Qualification Specialist III ensures that BioAtrium’s suppliers and materials qualification process and services associated are aligned with regulatory requirements, corporate standards, and agreements in place with shareholders.
This role is responsible for the oversight and compliance regarding the requirements set out in the respective agreement related to the services provided by the Shareholders regarding supplier and material qualification.
Additionally, the role ensures that all suppliers and raw material data and information is maintained up to date within the appropriate system, KPI associated with the scope of the role are collected and organized, while also timely escalating risks and issues.
Key Responsibilities:
* Establishes and maintains supplier qualification processes in line with GMP and regulatory requirements.
* Ensures supplier and raw material data is correctly recorded and maintained in quality systems.
* Manages qualification processes for raw materials used in manufacturing.
* Oversees change notifications, quality alerts, and deviations related to suppliers and materials.
* Collects and organizes material and supplier KPIs for monthly quality reports.
* Ensures timely escalation of quality issues and maintains compliance with ISO and GMP standards.
Key Requirements:
* Bachelor's or Master’s degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
* Strong knowledge of GMP regulations, pharmaceutical quality management systems, and compliance standards.
* Experience in managing quality tools, including SAP, LIMS, deviations, CAPA, and change controls.
* Problem-solving and decision-making skills in high-pressure environments.
* Ability to collect, organize, and report KPIs related to supplier and material qualification.
* Native-level English proficiency and beginner-level German skills.
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.
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