QA Manager Csv

vor 1 Tag

Stein, Schweiz Lonza Vollzeit

Switzerland, SteinToday, 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.

Key responsibilities:

- Responsible for Computerized System Validation (CSV) and Automation deliverables for new aseptic facilities, equipment and utilities related to the GMP manufacturing of drug products
- Representing Quality in the CAPEX project organization in regards to CSV and Automation
- Reviewing and releasing quality related CSV project deliverables
- Ensuring CSV deliverables meet Global procedures, regulatory requirements and policies
- Being a Subject Matter Expert (SME) and providing guidance and recommendations to internal and external project stakeholders

Key requirements:

- Academical degree (minimum Bachelor) in Engineering, Life Sciences or related field, or equivalent work experience
- Significant experience in the GMP regulated pharmaceutical industry project; preferable in a role within a Quality Unit
- Expertise in CSV, Data Integrity, Automation systems 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.)
- Sound knowledge of MES and DCS 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: R54026**:

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