-of-the-art technology and an efficient EMA system to optimize patient care. Highly competitive compensation with a robust...
Educational Records Bureau (ERB) and the Enrollment Management Association (EMA), E3n builds on nearly a century of collective...
and applicable FDA, EMA, and ICH regulatory guidelines Experience contributing to multidisciplinary scientific teams and cross...
in a quality assurance-related discipline preferred. In-depth knowledge of regulatory guidelines (FDA, EMA, USP, EP, JP...
internal and external stakeholders Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines...
manufacturing technologies Knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance...
knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing...
operations comply with FDA, EMA, ICH, and Annex 1 requirements. Maintain a culture of data integrity, continuous improvement... classification. Familiarity with regulatory expectations including FDA, EMA, ICH Q7-Q10, and Annex 1. Demonstrated leadership...
, bioburden, bioburden/endotoxin method suitability, plate enumeration, growth promotion, and BIs. Strong knowledge of FDA, EMA...
Life Ensure compliance with cGMP, ISO 9001, and applicable global regulatory requirements (FDA, EMA, etc.) Maintain...