, and compliance with FDA, EMA, and global GMP requirements. Essential Functions Reasonable accommodations will be made to enable... facility. Ensure sustained compliance and inspection readiness with applicable GMP regulations, including FDA, EMA, and global...
(FDA, EMA) on outsourcing and oversight obligations, proactively shaping EMP's process framework ahead of compliance risk...
suite used in daily work, including Microsoft Office (Excel, Word, Outlook), ModMed/EMA, Zoom, and Klara, to collaborate...) skills. Experience with the EHR/PM system Modernizing Medicine/EMA is a plus. Knowledge of California specific payer...
/ EMA Electronic Medical Record (EMR) highly preferred. Compensation The position will offer competitive compensation...
in a compliant manner in accordance with FDA, EMA and NN requirements Represent Facilities Engineering and actively participate...
CBER, EMA biologics, WHO TRS) and applicable ICH guidelines (Q5C, Q5E, Q6B, Q8–Q11) for biological products, including...
preferred Experience utilizing Modernizing Medicine / EMA Electronic Medical Record (EMR) highly preferred. Compensation...
with the EMA review process concluded positively in September 2023. It is an exciting time in the company’s development...
with the EMA review process concluded positively in September 2023. It is an exciting time in the company’s development...
of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.) in an aseptic environment...