Du bist der unabhängige Qualitätspartner für Qualifizierungs- und Validierungsteams und unterstützt sie bei der Entwicklung effektiver Strategien.
Anforderungen
- •Technischer oder naturwissenschaftlicher Abschluss
- •Mindestens 1 Jahr Erfahrung in GxP-Umgebungen
- •Erfahrung in Qualitätsmanagement, idealerweise in Medizintechnik
- •Unabhängige, agile, aufgeschlossene Teamfähigkeit
- •Fließend in Deutsch und Englisch (C1 oder höher)
Deine Aufgaben
- •Als unabhängiger Qualitätspartner für Qualifizierungs- und Validierungsteams handeln
- •Umfassendes Feedback, Überprüfung und Genehmigung von Validierungs- und Qualifizierungsunterlagen durchführen
- •Qualifizierungs- und Validierungsstrategien entwickeln und umsetzen helfen
Original Beschreibung
# Quality Assurance Analyst
**Rotkreuz** | **Part time**
### The Position
****A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.** **That’s what makes us Roche.****
****The position****
The Roche Diagnostics International Quality & Regulatory function governs the quality of our medical devices. Our quality assurance team ensures the highest standards for the Qualification & Validation activities performed by our business partners. They develop cutting-edge in-vitro medical devices, assays, laboratory information solutions and cloud-based offerings in the medical domain and include R&D, manufacturing and end user service organizations.
Our new global modular quality management brings a radical simplification of our process landscape and provides our validation and qualification teams with more freedom and ability to shape our future, while preserving our high quality standards.
## **Your responsibilities as a Quality Assurance Manager include, in particular:**
* Act as an independent Quality Partner for our qualification & validation business teams
* Perform comprehensive and independent feedback, review and approval of validation and qualification artifacts involved in the system life cycle
* Enable our business partners to develop and execute compliant and efficient qualification & validation strategies based on our global quality management system
****Who You Are****
* Technical or scientific degree or completed training in a technical profession, combined with at least 1 year of hands-on experience in qualification and/or validation in GxP-regulated environments.
* Experienced in quality management, particularly in equipment qualification or process validation, ideally within medical devices or in vitro diagnostics (ISO 13485, FDA QSR).
* Independent, agile, and open-minded team player with the ability to assert yourself..
* Fluent in both German (used for daily communication and documentation) and English (C1 level or higher; interviews conducted in German).
**Roche is an Equal Opportunity Employer.**