Senior Quality Assurance Specialist
vor 2 Monaten
Join Our Team at Lonza
About Us
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.
Our Mission
We are committed to making a meaningful difference in the lives of millions of people around the world. Our products and services have a positive impact on people's lives, and we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
About the Role
We are looking for a Quality Assurance Specialist 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.
- Checking and approval of master production records and electronic master batch records (EMBR); checking for consistency with approval documents, process descriptions, transfer documents, test plans, parameter lists, etc.
- Review of executed batch records within the defined timeline.
- Review of 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 Indicator (KPI) and Quality metrics and support QA department for internal and external meetings (batch tracker meetings, deviation review board, IPT, etc).
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.
Preferred Qualifications
- Experience with electronic batch records (execution and/or review).
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