Quality Assurance Manager

Vor 6 Tagen

Visp, Schweiz Lonza Vollzeit

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 Quality Assurance Manager (Batch Record Review Lead) (f/m/d) will be a member of a small QA Team that will ensure the quality oversight of mammalian drug substance facility. He/She will be leading a team of QA batch record reviewers that is responsible for review/ approval of manufacturing batch records.

Key responsibilities:

- Manages a team of QA Batch Record Reviewers
- Facilitate discussion within internal cross functional teams such as MSAT, Manufacturing and QC
- Perform batch record reviews in Manufacturing Execution System
- Review and approves Discrepancy Records, Change Requests and CAPA
- Review and approves SOP
- Supports cGMP training programs to ensure staff is trained
- Is involved in customer audits as well as regulatory inspections and supports all activities to ensure inspection readiness of department
- Perform other duties as assigned

Key requirements:

- Bachelor, Master degree or PhD in chemistry, biotechnology, life science or related field
- Sound years of experience in the GMP area within a pharmaceutical industry (preferably in the mammalian environment)
- Experience with Manufacturing Execution System (MES) is an advantage
- Strong leadership skills; very good communication skills and interaction with all kind of interfaces within the organization
- Structured, focused and well-organized working attitude; open-minded for new ideas, agile, highly motivated and solution-oriented
- Excellent knowledge of written and spoken English; good German skills advantageous

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.

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