Quality Assurance Csv Lead

vor 1 Woche

Visp, Schweiz Lonza Vollzeit

Switzerland, Visp

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.

For our biggest site in Switzerland, Visp we are looking for a Quality Assurance CSV Lead (f/m/d) to lead projects in the validation of computerized systems.

Key responsibilities:

- Owning all quality related responsibilities for the Computerized System Validation (CSV) activities of dedicated new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs
- Representative of Quality in the CAPEX project organization in regards to CSV
- Reviewing and releasing quality related CSV documents and quality procedures and policies
- Being a Subject Matter Expert (SME) and providing guidance and recommendations to internal or external customers

Key requirements:

- Bachelor or Master degree in computer science, engineering, life science or related field
- Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within a Quality Unit
- Broad knowledge in CSV, Data Integrity and related Guidelines (21 CFR Part 11, EU GMP Annex 11, GAMP5 and the underlying principles of each)
- Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
- Working knowledge of ERP (SAP), MES (Syncade) and DCS (DeltaV) is required
- Fluency in English, German would be an advantage

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.

**Reference: R44311**:
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