QA Analytics Raw Data Reviewer
vor 3 Wochen
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.
As a Quality Assurance (QA) Specialist for Analytics, you will perform QA raw data review for drug substances and drug products. This includes QC raw data review from QA and corresponding documentation preparation assuring their compliance to Lonza’s standards and customer’s requirements.
Key responsibilities:
- Control of QC raw data (drug product and Lonza GMP sales product)
- Planning and setting of deadlines together with QC.
- Organization of meetings, if necessary.
- Triggering and processing of deviations in this context.
- Creating new checklists for raw data verification and updating existing ones.
- Ensuring communication with the responsible QA and QC employees.
- Checking QC raw data (without release in LIMS)
- Release of LIMS calculations in DMS (Documentation Management System)
Key requirements:
- Bachelor in chemistry, biotechnology, life science or related field.
- 3 to 5 years of experience in the pharmaceutical industry, preferably in a QC or QA function.
- Founded analytical expertise.
- Strong background in cGMP regulations.
- Solution-oriented and strongly team-minded.
- Ability to oversee project execution to identify non-compliance from procedures. Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
- Excellent verbal and written communication in German and English.
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.
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