Associate Expert Quality Assurance | Biologe (m/w/d)
Octapharma Biopharmaceuticals GmbH
Job Summary
As an Associate Expert in Quality Assurance at Octapharma, you will play a critical role in maintaining the highest standards for virus and prion validation as well as neutralization testing. Your day-to-day responsibilities will include conducting facility and study-related inspections, reviewing GxP-relevant documentation, and contributing to the digitalization of SOP and form management. You will actively support authority audits, self-inspections, and the maintenance of validation documentation. Furthermore, you will be involved in Computer System Validation (CSV) activities, including data integrity controls and system testing, while managing Change Control, Deviation, and CAPA processes. This position is ideal for a detail-oriented professional looking to contribute to life-saving pharmaceutical research in a collaborative, modern environment. The role offers the unique opportunity to work within a global organization that maintains a family-oriented culture, focusing on the development of recombinant medicines that improve patient lives.
Required Skills
Education
Completed degree in a scientific or technical field (e.g., Bachelor or Master of Science) or equivalent qualification.
Experience
- 1-3 years of experience in IT compliance or Quality Assurance for computer-based systems (CSV).
- At least 1 year of practical professional experience with quality management systems such as GLP, GMP, or ISO 9001.
Languages
Additional
- Must be authorized to work in Germany. Role is based in Frankfurt am Main. Full-time position (40 hours/week).
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