Expert Associate in Impurity Risk Assessment

Expert associate in impurity risk assessment is actively participate in quality system processes by maintaining and compiling GMP documentation, including preparing and updating risk assessments related to potential genotoxic impurities in active ingredients, raw materials, and finished dosage forms while constantly looking for a ways to improve processes.

• Active participation in Quality system processes, Maintaining and compiling GMP documentation, such as initial preparation and updates of risk assessments regarding 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
• Ensure ongoing abidance by industry regulatory and quality requirements
• Drive improvements in Quality Documentation and processes
• Inspect data to detect areas for improvement
• Reference: 29itp_ok8898tqD3Vr8m-mxVWLlyefjC6HiiszcstcE.

• Faculty of Chemistry, Pharmacy or Technology; especially with advanced knowledge of organic synthetic chemistry
• First experience in the chemistry and analysis of (potentially genotoxic) impurities in low concentrations or quantities (ppm, ppb) preferred
• Active knowledge of the English language – B2 mandatory, C1 level advantage
• Advanced level of knowledge of MS Office package
• Excellent communication and negotiation skills
• Ability to work in a fast-paced, dynamic, environment

• 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