Senior QA Specialist Automation/EBR/BRR
vor 1 Tag
Lonza
Location:Visp
Job Category:Other
Job Reference:90f15181a215
Job Views:8
Posted:21.01.2025
Expiry Date:07.03.2025
Job Description:Today, Lonza is a global leader in life sciences operating across three continents. 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.
In Visp, we are looking for a QA Specialist Automation, EBR and Batch Record Review (f/m/d) (100 %) to build up our Vibe-X QA Operations team. You will report to a QA Vibe-X Operations team lead and work closely with various quality and operations functions to ensure the buildup and execution of cGMP compliant manufacturing and documentation processes in Vibe-X.
Key Responsibilities:
- Partner with internal customers for quality topics linked to set-up eBR in the Vibe-X project.
- Check and approve master production records and electronic master batch records (EMBR); ensure consistency with approval documents, process descriptions, transfer documents, test plans, parameter lists, etc.
- Review executed batch records within the defined timeline.
- Review minor deviations, investigations, and CAPAs within the defined due dates.
- Ensure that the batch records are closed and archived when all the activities batch related are completed.
- Contribute to the management and tracking of Key Performance Indicators (KPI) and Quality metrics and support QA department for internal and external meetings (batch tracker meetings, deviation review board, IPT, etc.).
- Perform other duties as assigned.
Key Requirements:
- Bachelor or Master of Science in chemistry, biotechnology, life sciences or another related field is an advantage.
- Experience in the GMP-regulated pharmaceutical/API industry.
- Ability to recognize non-compliance and gaps in quality standards.
- Structured, precise and well-organized work attitude; open-minded to new ideas and suggestions; agile, highly motivated and dynamic.
- Preference for a candidate that worked with electronic batch records (execution and/or review).
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.
Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.
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