Sterile Manufacturing Quality Expert
vor 4 Stunden
At Lonza, we excel in life sciences operating across three continents. Our success stems from talented individuals working together to devise innovative ideas that help businesses improve patient treatment. Join us in Drug Product Services, a successful branch located in Basel and Stein, Switzerland. We have exciting opportunities for you to become part of our team and make a difference.
About the RoleWe are seeking a seasoned Quality Assurance Expert for pharmaceutical QMS and combination products. In this role, you will be responsible for executing, establishing, and maintaining the Pharmaceutical Quality Management System at Drug Product Services for manufacturing of sterile products including combination products.
- Spearhead compliance topics as part of the QA Compliance team, including but not limited to CAPAs, self-inspections, KPIs, and assess GMP training requirements.
- Support the organization in creating and monitoring quality processes related to the relevant parts of the Quality Management System for combination products.
- Act as author and approve corresponding guidance documents and be the first point of contact concerning methods, validation, and testing for combination products.
- Track GMP status of service providers (e.g., calibration, maintenance, consultants) and track SAP material and supplier master data.
- Represent QA for the packaging team by approving methods, laboratory reports, and development activities.
This role requires significant working experience in Quality Assurance in pharmaceutical industries and GMP environment, preferably in sterile manufacturing. You should possess sound knowledge in compliance systems for document life cycle management, workflow tools (e.g., Document Management System), and processes for sterile Drug Product manufacturing including testing.
Key Requirements- Exceptional communication skills with a customer-focused approach (internal/external).
- Excellent knowledge of written and spoken English, with basic knowledge of German.
What We Offer
As a Quality Assurance Expert at Lonza, you will have the opportunity to work in a dynamic environment with a global leader in life sciences. Our company values collaboration, innovation, and customer satisfaction. If you are a motivated individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
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Zürich (Kreis 1) / City, Zürich, Schweiz Lonza VollzeitCompany OverviewLonza is a global leader in life sciences, operating across three continents. Our success lies in the collaboration of talented individuals devising innovative solutions to help businesses improve patient treatment.
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