Quality Control Expert | QC Expert (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
This role is for a dedicated Quality Control Expert to manage and coordinate complex QC processes for biopharmaceutical products within an innovative pharmaceutical company in Ochsenhausen, Germany. The position involves the planning, coordination, and evaluation of critical QC activities, including stability studies, sample management, and material releases. A core responsibility is ensuring strict adherence to GxP regulations and coordinating extensive GMP documentation, particularly managing complex deviation and change requests. The expert will also independently interpret and present complex test results to internal stakeholders, partners, or regulatory authorities, requiring strong written and verbal communication skills in both German and English. Candidates must hold a Master of Science in a relevant natural science field (e.g., Chemistry, Pharmacy) or equivalent training, coupled with significant professional experience and deep knowledge of GMP and Quality Management Systems (like Trackwise). This position offers a hybrid work model (up to 2 days remote) and is initially limited to 18 months with a strong option for extension.
Required Skills
Education
Master of Science in Chemistry, Biochemistry, Pharmacy, or comparable Natural Science field; or completed vocational training in relevant fields
Experience
- Several years of professional experience in a relevant field (required with Master's degree)
- Long-standing relevant professional experience in the pharmaceutical environment (required with vocational training)
- Deep knowledge and practical experience in the GMP environment
- Practical experience with Material Releases and/or analytical issues
- Practical experience with Quality Management Systems (e.g., Trackwise)
Languages
Additional
- Initial contract duration of 18 months (with option for extension); Ability to work in a hybrid model (2 days remote per week); Must be able to work under pressure and tight deadlines.
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