(Senior) Specialist Quality Control | (Senior) Specialist Qualitätskontrolle (m/w/d)
QIAGEN GmbH
Job Summary
This role at QIAGEN in Hilden (near Düsseldorf) focuses on ensuring the quality and integrity of laboratory systems and processes. The successful candidate will be responsible for planning, executing, documenting, and verifying qualification and validation activities, as well as managing change processes. This involves close collaboration with IT, Quality Assurance, and other departments. Key responsibilities include supporting the introduction of new technologies in a regulated lab environment, installing and validating lab equipment, and managing IT/OT infrastructure to ensure data integrity and compliance with regulatory requirements like GMP, 21 CFR Part 11, and IVDR. This position is ideal for a professional with a scientific or technical background who is passionate about making a tangible impact on scientific research and healthcare.
Required Skills
Education
Bachelor's or Master's degree in a scientific or technical field
Experience
- Several years of professional experience with a Bachelor's degree, or initial demonstrable professional experience with a Master's degree
- Experience in planning, execution, and GMP-compliant documentation of qualifications (DQ/IQ/OQ/PQ) and validations, including change management
- Knowledge in creating requirement profiles, specifications, risk analyses, and traceability matrices in both laboratory and IT environments
- Demonstrable knowledge of regulatory requirements (e.g., GMP, 21 CFR Part 11 / EU GMP Annex 11, IVDR, ISO 13485)
Languages
Additional
- Not specified
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