QA Officer (m/f/d)
QA Officer (m/f/d)
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ADCs / Bioconjugates
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Drug Substance (API)
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cGMP manufacturing
Allogeneic
Autologous
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QA Officer (m/f/d)
Netherlands, Geleen
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 Quality Officer supports the department and site in publishing of metrics and reports and meeting coordination of projects. The QA Officer interacts directly with internal customers on change, CAPA and Deviation management, documentation and projects while being mentored by a senior QA Officer/ QA Project Manager. Capable of identifying and resolving Quality issues with assistance. The QA Officer will ensure superior customer service to internal customers Key Responsibilities: Partner with internal customer as part of minor change requests, CAPA and Deviations. Review and prepare the batch records for QP's batch disposition and review of related deviations, CAPAs and Change Requests within the defined due dates. Ensure that the batch records are closed and archived when all the activities batch related are completed. Review and approve Lonza documents such as SOPs, forms, master batch records, test methods, checklists, etc. Participate in QA On the floor tasks such as witnessing manufacturing/production support/warehouse/quality control activities. Manage and track Key Performance Indicator (KPI) and Quality metrics and support QA department for internal and external meetings (batch tracker meetings, deviation review board, IPT, etc). Flexibility to do shifts when needed to ensure QA OTF tasks are performed and that batch disposition of product with short expiry date can be done on time. Perform other duties as assigned. Key Requirements: B.Sc. or M.Sc. level of thinking & working. Relevant working experience 2 to 3 years Dutch working permit 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 .
Reference: R58930
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