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Deze vacature is niet meer vacant: Senior CSV Specialist

Werkgever:Lonza
Plaats:Geleen

Oorspronkelijke vacature omschrijving:

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 CSV Specialist reviews and approves documentation and oversees computerized system validation deliverables. The candidate will review and approve the computerized system validation documents and procedures associated with computerized system operation, cleaning and maintenance, design and configuration specifications, Electronic Records and Electronic Signatures (ERES) and Data Integrity Risk Assessments (DIRA). The candidate will provide computerized system and application support and conduct administration of GxP computerized systems.

Key responsibilities:

  • Overseeing computerized system validation (CSV):
  • Review and approve computerized systems URSs;
  • Review and approve risk assessments associated with computerized systems;
  • Review and approve design and configuration specifications;
  • Review and approve server installation plans and qualification;
  • Review and approve computerized systems validation test scripts;
  • Review and approve computerized systems validation reports;
  • Review and approve Electronic Records and Electronic Signatures (ERES);
  • Review and approve Data Integrity Risk Assessments (DIRA)

Key requirements:

  • Bachelor degree in IT/Biology/Biomedicine
  • Experienced with Quality Management and GxP Regulations
  • Knowledge of validation methodologies
  • Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP
  • Knowledge of the manufacturing processes

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. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.