Senior Quality Assurance Specialist
vor 2 Wochen
Lonza is 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.
We are looking for a QA Specialist to support our team in QA plant qualification.
Key Responsibilities:- Represent the QA Qualification interest in project organization for new facilities or other projects.
- Coordinate different QA interests during the project phase.
- Drive implementation of new qualification strategy and make key decisions when needed.
- Compile, review and release Qualification Documents and support quality risk analysis.
- Perform assessments and approvals of technical changes requests.
- Represent qualification topics during customer audits and regulatory inspections.
- Ensure CAPA and Effectiveness Checks items are completed on time and deviations are appropriately investigated.
Requirements:
- Bachelor's degree in engineering, Chemistry, Biotechnology or a related field.
- Significant experience in the pharmaceutical industry, ideally in a QA role.
- Good understanding of cGMP regulations would be an advantage.
- General knowledge of engineering and manufacturing processes.
- Able to oversee project execution to identify non-compliance from quality standards.
- Fluent language skills in German and English are required.
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