QA Project Manager

vor 5 Monaten

Visp, Schweiz Lonza Vollzeit

Switzerland, VispToday, 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.

In Visp, we are looking for a QA Specialist (f/m/d) to extend our team. You will report to the QA Operations Teamlead Microbial and work in close collaboration with different quality and operations functions in order to ensure cGMP-compliant manufacturing activities and documentation.

Key responsibilities:

- Owns all quality-related responsibilities for the daily activities (like campaign preparation, change control, deviation & CAPA management, process monitoring) of API manufacturing processes for clinical and commercial supply.
- Ensures an efficient cGMP-compliant life cycle management of all products manufactured and has the authority to make quality decisions for the project in internal and external meetings
- Main customer point of contact for all project-related quality requests
- Providing cGMP guidance to all Lonza departments and assessing project-specific risks and internal adherence to cGMP by identifying areas of non-compliance through risk assessments
- Project responsible for internal & external audits; QA SME for client's audits and participation in regulatory inspections of health authorities

Key requirements:

- Bachelor or Master of Science in life science (e.g. chemistry, biotechnology or other related field)
- Experience in the GMP-regulated pharmaceutical / API industry is an advantage
- Ability to identify non-compliance and gaps from quality standards
- Experience collaborating closely with different functions and departments
- Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
- Fluency in the English language and basic German skills are 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: R59228

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