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Senior Quality Assurance Specialist
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Visp, Schweiz Lonza VollzeitSenior QA SpecialistLonza is a global leader in life sciences, operating across three continents. We're looking for a Senior QA Specialist to join our team in Visp, Switzerland.The Role:As a Senior QA Specialist, you will be responsible for ensuring the quality of our manufacturing facilities, processes, and products. You will support the end-to-end...
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Senior Quality Assurance Specialist
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Visp, Schweiz Lonza VollzeitJoin Lonza's Team as a Senior QA SpecialistLocation: Visp, SwitzerlandHybrid Work Model: 3 days in the office, 2 days WFHLonza is a global leader in life sciences, operating across three continents. Our success is built on talented people working together to devise innovative solutions that improve lives worldwide. In exchange, we empower our employees to...
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Senior Quality Assurance Specialist
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Senior Quality Assurance Specialist
vor 2 Wochen
Visp, Schweiz Lonza VollzeitJoin Lonza's Quality Assurance TeamAs a Senior QA, Change Control Specialist, you will play a critical role in ensuring the quality and compliance of our products and services. Your expertise will be essential in maintaining our high standards of quality and regulatory compliance.Key Responsibilities:Own and manage quality records, including change controls,...
Senior QA, Change Control Specialist
vor 4 Monaten
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 member of the QA Projects and Change Controls group in BioAtrium, the Change Control Specialist (f/m/d) supports in QMS GMP compliance (e.g. hosting CCRB, supporting raising and closure of changes), promotes the adherence and continuous improvement of Quality Systems and ensures Quality oversight in the specified area.
Key responsibilities:
- Owns quality records such as change controls, CAPAs, investigations, effectiveness checks in line with valid SOPs
- Leads the Change Control Review Board (CCRB)and CAPA Review Board (CRB) as required
- Hosts change control clinics to support Production, MSAT, validation, CQV and other Quality members with change controls
- Authors, reviews and approves GMP-relevant documents and SOPs in the ownership of QA
- Supports and participates in internal, customer and regulatory audits
- Electronic batch record: recipe review and approval
- Support continuous improvements programs to establish effective Quality Management Systems
Key requirements:
- Bachelor or Master Degree in life sciences (e.g. chemistry, biotechnology or a related field)
- Significant work experience in the GMP-regulated industry; preferably in the following units: Production, QC or QA, Operations
- Broad knowledge in Quality standards (e.g. ICH Q7, 21 CFR Part 11
- Knowledge of electronic systems such as Delta V, Syncade, SAP, LIMS, Trackwise an advantage
- English language skills (written and spoken) are required, German is an advantage
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: R61366Apply Switzerland, Visp