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Regulatory Labeling Expert Pharmaceutical
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Regulatory Labeling Expert Pharmaceutical
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Head of Quality Systems and Compliance
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Visp, Schweiz Lonza VollzeitAbout the RoleAt Lonza, we're a global leader in life sciences, operating across three continents. Our greatest scientific solution is talented people working together to devise ideas that help businesses improve lives. In return, we empower our people to own their careers, creating a culture where ideas genuinely improve the world.Your Key...
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Visp, Schweiz Lonza VollzeitQuality Assurance Manager for Global IT InfrastructureLonza, a global leader in life sciences, is seeking a Quality Assurance Manager for Global IT Infrastructure to support the entire organization worldwide. As a key member of the QA department, you will collaborate with the IT department to develop and implement infrastructure-related business processes...
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Senior Quality Assurance Manager
Vor 5 Tagen
Visp, Schweiz Lonza VollzeitJob Summary:The Senior Quality Assurance Manager will be responsible for ensuring that all manufacturing processes and cleaning processes for manufacturing equipment throughout their lifecycle are performed and validated in compliance with cGMP requirements and internal/external quality standards.Key Responsibilities:Develop and implement Process Validation...
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Manager, Msat Process Validation
vor 5 Monaten
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, 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...
Regulatory Compliance Manager
vor 2 Monaten
About Lonza
Lonza is a global leader in life sciences, operating across three continents. Our success is built on the talent and expertise of our people, who work together to develop innovative solutions that improve lives around the world.
Job Summary
We are seeking a highly skilled Change Control Specialist to join our QA Projects and Change Controls group in BioAtrium. As a member of this team, you will play a critical role in ensuring the quality and compliance of our products and processes.
Key Responsibilities
Own and maintain quality records, including change controls, CAPAs, investigations, and effectiveness checks, in accordance with valid SOPs.
Lead the Change Control Review Board (CCRB) and CAPA Review Board (CRB) as required.
Host change control clinics to support Production, MSAT, validation, CQV, and other Quality members with change controls.
Author, review, and approve GMP-relevant documents and SOPs within the ownership of QA.
Support and participate in internal, customer, and regulatory audits.
Review and approve electronic batch records, including recipe review and approval.
Contribute to continuous improvement programs to establish effective Quality Management Systems.
Requirements
Bachelor or Master's Degree in life sciences, such as chemistry, biotechnology, or a related field.
Significant work experience in the GMP-regulated industry, preferably in Production, QC, or QA, Operations.
Broad knowledge of Quality standards, including ICH Q7 and 21 CFR Part 11.
Knowledge of electronic systems, such as Delta V, Syncade, SAP, LIMS, and Trackwise, is an advantage.
English language skills (written and spoken) are required, with German being an advantage.
About Working at Lonza
At Lonza, we value our people and our environment. We strive to achieve business results while respecting and protecting our people and the environment. We offer a dynamic and challenging work environment where you can develop your skills and expertise, and make a meaningful difference in the world.
