Senior QA Specialist, Bioconjugates 80-100%
vor 3 Wochen
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.
For Ibex Solutions (www.ibex.lonza.com), our unique biological manufacturing and development concept in Visp, Switzerland, we have an opening. Become a part of this exciting opportunity and join our team by applying for the position of a Senior QA Specialist (f/m/d) for one of our Ibex bioconjugate manufacturing plants.
In this role you will specify quality requirements for manufacturing processes and ensure that manufactured products comply with cGMP standards over their entire life cycle. As a Quality representative, you will be a key member in cross-functional project teams ensuring measures for product safety, quality & compliance are implemented. You will have full QA oversight of a product and manage the project from a Quality perspective.
Key responsibilities:
- Own all quality-related responsibilities related to new facility operational readiness and manufacturing processes and represent QA in project organization.
- Perform assessments for all process-related changes and be responsible for review and final approval of records such as Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Quality Risk Assessments, Deviations, CAPAs, Change Requests, Effectiveness Checks, Testing Protocols & Reports, etc.
- Support the release of Drug Substance batches.
- Support the investigations of customer product complaints and assure the completion of the appropriate documentation.
- Represent QA in project/tech transfer organizations for new biotech manufacturing processes and coordinate QA interests during the different project phases.
- Make quality decisions for the respective projects in internal and external meetings.
- 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 Biotechnology / Biology / Chemistry / Life Science or related field.
- Significant experience in the area of biopharmaceutical manufacturing, preferably in a QA function.
- Strong background in cGMP and broad knowledge in biotechnological manufacturing processes, validation approaches, and risk management.
- Good communication skills and experience in interaction with all kinds of interfaces within the organization and with regulatory agencies (Swissmedic, FDA, etc.).
- Experience in the use of the following systems would be preferred: TrackWise, LIMS, DMS, and SAP.
- Proficient written and spoken English; good German language skills - an advantage.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. 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. The satisfaction that comes with making a meaningful difference.
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