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CSV Specialist
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Geleen, Nederland Lonza VoltijdCSV Specialist 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...
CSV Specialist
1 maand geleden
Job Title: CSV Specialist
Job Summary: We are seeking a highly skilled CSV Specialist to join our team at Lonza. As a CSV Specialist, you will be responsible for leading Computerized System Validation activities and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Develop and execute validation plans, protocols, and test scripts to meet 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP 5 requirements.
- Conduct gap assessments and remediation plans to identify and address validation gaps.
- Support regulatory and client audits as a CSV subject matter expert.
- Collaborate with the Engineering group to prepare the validation, requalification, and maintenance program.
Requirements:
- Bachelor's degree in a relevant field.
- Demonstrable experience in CSV in a GMP environment.
- Excellent understanding of good documentation practices, data integrity, and ALCOA++.
- Knowledge of 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP 5.
About Lonza: Lonza is a global leader in life sciences operating across three continents. We are committed to improving lives through innovative solutions and a strong focus on ethics and sustainability.
