QA Project Manager - Visp, Schweiz - Lonza
Beschreibung
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 qualityrelated 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 cGMPcompliant 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 projectrelated quality requests
- Providing cGMP guidance to all Lonza departments and assessing projectspecific risks and internal adherence to cGMP by identifying areas of noncompliance 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 GMPregulated pharmaceutical / API industry is an advantage
- Ability to identify noncompliance and gaps from quality standards
- Experience collaborating closely with different functions and departments
- Structured, precise and wellorganized working attitude; openminded for new ideas and suggestions; agile, highly motivated and dynamic drive.
- Fluency in the English language and basic German skills are an advantage
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
- Reference: R59228
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