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QA Manager eBR (f/m/d)
View: 154
Update day: 04-04-2024
Category: Quality Assurance / Quality Control
Industry: Human Resources Services
Position: Mid-Senior level
Job type: Full-time
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Job content
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 site in Visp, Switzerland is growing and for our Biologics Quality organization, we are currently looking for a QA Manger Electronic Batch Record for Large Scale Mammalian in Ibex® Solutions, our recently launched unique biological manufacturing and development concept. The successful candidate will be responsible for quality oversight of the automated process landscape in the large scale mammalian organization.Key Responsibilities- Execute and ensure GMP compliance according to established quality standards and GMP regulations
- QA Responsible for master batch records.
- Manage, improve and optimize documentation, batch record review process.
- Managing the review and approval of executed electronic batch records (eBRs), for consistency with approval documents, process descriptions, transfer documents, test plans, parameter lists etc.
- Review of manufacturing and batch record-related SOPs.
- Quality oversight of the automated process landscape.
- Be the point of contact for batch records quality-related questions and resolve issues originating from manufacturing operations.
- Ensure a continuous liaison with Batch Record Review team and Operations to meet deadlines and ensure a timely batch disposition execution.
- BSc. in IT, Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent.
- Working experience in Quality Assurance/manufacturing/Quality Control/IT, ideally in the pharmaceutical industry.
- Experience in QA batch documentation review process is preferable.
- Experience with automated manufacturing systems, e.g. Syncade MES is desired.
- Knowledge of EU and US GMP regulations.
- Strong affinity to automation and IT.
- Fluency in English, able to communicate in or willing to learn German.
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Deadline: 19-05-2024
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