Expert Associate in Impurity Risk Assessment Team

Expert Associate in Impurity Risk Assessment actively participates in quality system processes by maintaining GMP documentation and preparing risk assessments related to potential genotoxic impurities in various products. They evaluate documentation from manufacturers according to ICH and EMA guidelines, initiate analyses of genotoxic impurities in external laboratories, and drive improvements in quality documentation while ensuring compliance with regulatory standards.

• Active participation in Quality system processes, Maintaining and compiling GMP documentation, such as initial preparation and updates of risk assessments in regard to possible formation of genotoxic impurities in active ingredients, raw materials, finished dosage forms and others
• Evaluating documentation from manufacturers and suppliers in line with the applicable ICH and EMA guidelines
• Initiate analysis of respective genotoxic impurities in external laboratories and evaluate testing results
• Ensure ongoing abidance by industry regulatory and quality requirements
• Drive improvements in Quality Documentation and processes
• Inspect data to detect areas for improvement
• Reference: z1br7pT_QsVUfp9AtiVUKye_-TGFd6itHh8Nq68fqALN-bDGSxoJSRD0ISq0GvzR

• Faculty of Chemistry, Pharmacy or Technology
• First experience in the chemistry and analysis of (potentially genotoxic) impurities in low concentrations or quantities (ppm, ppb) is plus
• Active knowledge of the English language – B2 mandatory, C1 level advantage
• Advanced level of knowledge of MS Office package
• Excellent communication and negotiation skills
• Team-oriented, precise, analytical, responsible, independent
• Fast learner and easily adaptable to changes

• Private healthcare insurance (with the option of privileged usage for family members)
• Ongoing professional development through specialized education and training
• A platform for learning 14 foreign languages, using various learning styles, including conversation courses
• Personalized mental health and well-being support for employees and their families through the Kyan Health app