and oncology with key Health Authorities, e.g. FDA, EMA/CHMP, PMDA, MHRA Expertise in scientific, medical and commercial...
. Calibrate and maintain a wide variety of instrumentation in regulated environments (FDA, EMA) and under ISO quality standards...
, implement, and maintain the global PV audit strategy, ensuring alignment with regulatory expectations (e.g., EMA, FDA, MHRA...
, verification, and transfer activities in alignment with ICH, FDA, EMA, and internal SOPs Draft, review, and approve validation...
Regulatory Knowledge Management: Demonstrated understanding of regulatory requirements (U.S. FDA, EMA, Health Canada...
Regulatory Knowledge Management: Demonstrated understanding of regulatory requirements (U.S. FDA, EMA, Health Canada...
(FDA, USDA, EMA) Experience with quality standards such as GMP Additional Information Travel: Approximately 10...
preferred Experience utilizing Modernizing Medicine / EMA Electronic Medical Record (EMR) highly preferred. Compensation...
). Maintain accurate and up-to-date patient charts, demographic, and insurance information in EMA. Maintain a clean, organized... information into EMA. Update and maintain the PA log, ensuring accuracy of codes and documentation. Financial & Payment...
qualifications): Demonstrated success in auditing aseptic or sterile manufacturing platforms under FDA, EMA, or similar regulatory...