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Quality Management System Specialist, 12 months (f/m/d)
Vue: 225
Jour de mise à jour: 26-03-2024
Catégorie: Assurance Qualité / Contrôle Qualité
Industrie: Information Technology Services Biotechnology Pharmaceuticals
Niveau: Entry level
Type d’emploi: Full-time
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le contenu du travail
Today, 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 order to support the strategic growth investment of the company in Visp, Switzerland, we are looking for a Quality Management System specialist
Key Responsibilities
- Develops, maintains and implements the Quality Management System to ensure that products meet intended specifications for safety, quality, purity and identity
- Responsible for coordinating, defining and organizing customer/shareholder audits and regulatory inspections including
- Definition, training and preparation of Front Office and Back Office teams
- Organization of preparation meetings and SME training sessions and coordination with SMEs before audit/inspection
- Manages audit/inspection readiness, leading readiness meetings, tracking gaps, etc
- Maintains the audit records in TrackWise, incl. opening CAPAs for audit/inspection observations. Reviews the proposed measures and due dates submitted by the SMEs and requests adjustments if necessary
- Creates or reviews and approves SOPs in area of expertise
- Bachelor’s degree in life sciences required
- Well organized, self starter, high grade of autonomy
- Good use of IT tools (e.g. Excel, Power Point, Word, Share Point)
- Provides suggestions for improvement to documentation and workflows
- Knowledge of GMP would be an advantage
- Prior basic experience with SAP, Trackwise are a plus
- Excellent verbal, written and interpersonal communications skills
- Fluency in English, German would be an advantage
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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Date limite: 10-05-2024
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