Quality Manager for Computerized System Validation - Rotkreuz, Schweiz - Coopers Group AG

Coopers Group AG

Geprüftes Unternehmen

Rotkreuz, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

Quality Manager for Computerized System Validation

For our Pharma client in the canton Zug, we are currently looking for a Quality Manager for Computerized System Validation

Start date:

ASAP

End date:

Home Office:
possible

Tasks & Responsibilities:

Act as an independent Quality Partner for our qualification & validation business teams (in particular for computerized system validation CSV)
Enable our business partners to develop and execute compliant and efficient validation strategies based on our global quality management system
Perform comprehensive and independent feedback, review and approval of all validation and qualification artifacts involved in the system life cycle
Based on a deep understanding of our global quality management system: act as ambassador of the global quality assurance processes and thereby enable our business partners to deliver high class medical products
Shape, live and defend our global quality management system

Must Haves:

Min. technical or scientific degree (FH/HF/University degree) or completed education in a technical profession (e.g. Computer Sciences, electrical engineering or IT)
Min. 35 years practical expertise in the area of qualification and validation
Experience in a GxP regulated environment
Experience with quality management in the area of medical devices or in vitro Diagnostics (based on ISO 13485, FDA and Quality Systems Regulations)
Fluency in English spoken and written
German at least B1. Level (no certification needed)
Pragmatically achieving highest quality standards while keeping stakeholders happy is your passion
Good judgment, negotiation and communication skills, ability to prioritize tasks
Autonomous, flexible, agile and openminded team player with the ability to assert yourself

Nice to Have:

Experience in the areas Artificial intelligence, Cloud solutions, Data integrity and CI/CD (continuous integration / continuous deployment) is considered a plus

Sounds like a great job?