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Job Description Summary The future is ours to shape. / Prihodnost je v naših rokah. Job Description As a (Senior) QC Specialist in the bioanalytical laboratory , you will play a key role in its establishment, the design of laboratory processes, and the implementation of analytical methods. This is an exceptional opportunity to actively contribute to laying the foundation for the successful operation of the laboratory. Being a part of a dynamic and interdisciplinary team, you will gain valuable professional expertise and contribute to ensuring compliance with regulatory requirements and the high quality of bioanalytical tests that support commercial products. Your key responsibilities: Your responsibilities include, but not limited to: Active involvement in the handling of deviations (e.g. out-of-specification results - OOX) and leading and implementing corrective and preventive actions (CAPA). Support in the transfer of analytical methods: preparation of documentation, training of colleagues, and transfer of expert knowledge. Review and approval of analyses in accordance with GMP for analytical release purposes. Participation in internal and external inspections. Preparation and revision of documentation (Standard Operating Procedures - SOP, Work Instructions - WP, equipment qualification, and others). Good understanding of biological tests and the ELISA (Enzyme-Linked Immunosorbent Assay) method. Support to colleagues in daily tasks and resolving technical challenges. Active role in organizing and establishing an efficient bioanalytical laboratory. What you will bring to the role: Completed at least Master's level degree in a natural science field - biology, biochemistry, biotechnology, microbiology, laboratory biomedicine, or a related discipline. At least two years of experience in a GMP environment (for a senior position, at least five years of relevant experience). Candidates with experience in the pharmaceutical industry and in the quality control department are preferred. Knowledge and practical experience with cell culture work is desirable. Proficient in English (written and spoken). Computer literacy. High level of accuracy, responsibility, and ability to work in a team; well-developed communication skills; ability to make independent decisions and solve problems efficiently; adaptability, proactivity, and willingness to engage in continuous learning.
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