Quality Specialist
vor 3 Wochen
At D104 Alcon Deutschland GmbH Company, we are driven by the meaningful work we do to help people see brilliantly. As a global leader in eye care, we strive for innovation and progress, and we act quickly. We reward your engagement and performance, and you can advance your career like never before. Together, we go beyond to improve the lives of our patients and customers. We foster a culture that includes everyone and seek out diverse, talented individuals who want to join Alcon.
As a Quality Specialist, you will support the team responsible for quality processes and be responsible for maintaining and monitoring the quality management system at our Freiburg im Breisgau location.
A Typical Day in this Role- Maintenance and monitoring of the quality management system, including evaluation of deviations in the CAPA process, tracking of measures, and performance of effectiveness checks
- Performance of routine tasks such as product release, monitoring of storage conditions, and redress activities in accordance with local regulations, GxP standards, and ISO 13485
- Performance of corrective actions and support for market actions, including communication with authorities and affected customers
- Qualification and risk assessment of suppliers, creation of quality assurance agreements, and performance of audits as an Alcon auditor (leading or supporting)
- Support for annual management reviews, training of SOPs and work instructions, and performance of internal GMP and GDP training for other departments
- Verification of analysis certificates, release of pharmaceutical products and medical devices in SAP, and processing of quality inquiries
- Completed studies in a pharmaceutical, technical, or natural sciences field
- At least 1 year of experience in quality management in a regulated industry
- Knowledge of Microsoft Office and SAP (or other ERP system)
- Ability to analyze and evaluate data, particularly in the CAPA process
- Fluent German and English skills in writing and speaking
- Independent, proactive, and flexible working style
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