Stability Technician / Analytical Method Validation Specialist

Description

Job Summary: We are seeking an experienced professional to manage stability studies and validate analytical methods under ICH guidelines, collaborating with other key departments. Key Highlights: 1. Management of stability studies and analytical validation under ICH guidelines 2. Analysis of results and interdepartmental collaboration 3. Use of advanced analytical techniques such as HPLC, UV, and IR We seek a professional with experience conducting stability studies under international regulations, including those of ICH. Your responsibilities will include organizing and closely monitoring stability study schedules, ensuring all scheduled analyses are completed within defined deadlines. This requires detailed planning and continuous oversight to meet established timelines. The position also involves analytical method validation using various techniques, such as HPLC, UV, and IR, in accordance with ICH Q2(R2) and other applicable regulations. You will draft protocols and comprehensive reports for both validations and stability studies. Analysis of results will be fundamental, participating in the investigation of any result deviating from expected outcomes or usual trends. Strong ability to collaborate seamlessly with other key departments—including Manufacturing, Quality Assurance, and Regulatory Affairs—will be highly valued. Teamwork and effective communication skills will be essential to achieving shared goals in Barcelona. A university degree (Bachelor's or Higher Vocational Training) in Chemistry, Pharmacy, Biotechnology, or a related field is required. A minimum of 2–5 years of experience in a pharmaceutical laboratory is required. Demonstrable experience in conducting stability studies and analytical validation is mandatory. Experience handling analytical techniques such as HPLC, GC, UV-Vis, Karl Fischer, and dissolution testing is required. Proficiency in chromatographic software and LIMS is necessary. Knowledge of regulations such as ICH (Q1A, Q2) and GMP is essential. A medium-to-advanced level of technical English is required.