Quality Manager for Computerized System Validation

vor 2 Wochen

Rotkreuz, Schweiz Work Selection Vollzeit

**Beschreibung**:
For our international medical partner, Roche Diagnostics International Ltd. in Rotkreuz, we are looking for a qualified and motivated **Quality Manager for Computerized System Validation** for one year with option for extension.

Our client is looking for an additional Infrastructure Partnering Team member in the area of Computerized System Validation (CSV). The position offers a close collaboration with their internal business partners in Global Customer Support, Roche Information Solutions but also interaction with Roche's Integrated Informatics (IT). Together with their partners, they develop, derive and approve validation strategies based on cutting edge technology (like artificial intelligence).

**Tasks**:

- Act as an independent Quality Partner for the qualification & validation business teams (in particular for computerized system validation CSV)
- Enable the business partners to develop and execute compliant and efficient validation strategies based on their 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 their global quality management system: act as ambassador of the global quality assurance processes and thereby enable their business partners to deliver high class medical products
- Shape, live and defend their global quality management system

**Must Haves**:

- Minimum technical or scientific degree (FH/HF/University degree) or completed education in a technical profession (e.g. Computer Sciences, electrical engineering or IT)
- Minnimum 3-5 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 on 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 open-minded team player with the ability to assert yourself

**Nice to Haves**:

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

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