Quality Assurance and Compliance Specialist
Vor 4 Tagen
Siegfried DINAMIQS is a Contract Development and Manufacturing Organization (CDMO) based in Switzerland, specializing in the manufacturing of viral vectors for gene therapies.
We offer a comprehensive range of services, including vector design optimization, process development, and analytics. Our state-of-the-art R&D facility supports gene therapy projects with scalable solutions.
As part of Siegfried's global network, we are dedicated to growing our team of experts by hiring a Quality Assurance Specialist.
In this role, you will play a crucial part in establishing our new GMP facility. You will assist in implementing quality systems, qualifying the facility, and planning workflows to support GMP compliance.
You will manage documentation control systems, prepare facilities for regulatory inspections, and review quality documents. Additionally, you will support supplier qualification, act as the primary QA contact on the shop floor, and conduct root cause analysis.
A B.Sc or M.Sc in Biotechnology, Virology, or Molecular Biology is required. At least 5 years of experience in a GMP-regulated biopharmaceutical environment, with at least 2 years in QA, is expected.
You should have strong knowledge of viral vector production processes, regulatory requirements, and industry guidelines. Excellent analytical, problem-solving, communication, and interpersonal skills are essential.
What you can expect:
- A unique work experience in a dynamic, inclusive CDMO
- Competitive compensation
- Flexible working hours and holidays
- Impactful work in innovative gene therapy projects
- Diverse skills development in a fast-paced environment
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