Senior QA Specialist, Operations Drug Substance 80-100%
vor 4 Wochen
Senior QA Specialist, Operations Drug Substance 80-100% (f/m/d)
Today, Lonza is a global leader in life sciences operating across three continents. 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, and their ideas genuinely improve the world.
For Ibex Solutions (www.ibex.lonza.com), we have an opening for a Senior QA Specialist, Operations Drug Substance (f/m/d) for one of our Ibex manufacturing plants in Visp, Switzerland.
In this role, you will be a member of a small QA team ensuring quality oversight of the facility and drug substances produced therein. You will be involved in transfers of manufacturing processes, reviewing and approving manufacturing SOPs and recipes, and releasing or rejecting drug substances on behalf of the responsible person.
Key responsibilities:
- Responsible for defining the bill of materials and involved in all activities required to qualify raw materials.
- Facilitate discussions within internal cross-functional teams such as MSAT, Manufacturing, and QC.
- Review and approve manufacturing recipes and perform batch record review and approval in the Manufacturing Execution System.
- Review and approve Discrepancy Records and Change Requests.
- Support the definition of preventive and corrective measures (CAPAs), approve them, and track their timely implementation and effectiveness.
- Support the release of Drug Substance batches.
- Review and approve SOPs and project-related documents; support and approve quality risk analysis (e.g., FMEA); write or revise SOPs in own area of expertise.
- Involved in customer audits as well as in regulatory inspections and support all activities to ensure inspection readiness of the department.
Key requirements:
- University Degree in natural sciences – preferred in Biology or Biotechnology.
- Significant experience within the GMP-related environment and preferably in a QA role.
- Proficient in MS Office; experience in TrackWise, LIMS, SAP preferred.
- Fluent in English; German language skills are an advantage.
Every day, Lonza’s products and services have a positive impact on millions of people. We respect and protect our people and our environment, and any success we achieve is no success at all if not achieved ethically.
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.
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