results in manufacturing operations Knowledge of FDA, EMA and cGMP regulations Desired Qualifications Bachelor...
, deviation management, and change control. Strong knowledge with regulatory standards (e.g., ISO, FDA, GMP, EMA). Excellent...
communications skills. Willingness and ability to self-educate in new areas. Knowledge of FDA, EMA, and ICH regulations...
) requirements Knowledgeable in FDA, EMA, GxP and ICH regulatory requirements. Good working knowledge of GxP facility/equipment...
Device industry and product labeling Knowledge of labeling within a Therapeutic Area Knowledge of FDA, or EMA...
and qualification of new mechanical systems, ensuring they meet all GMP, FDA, and EMA requirements. Implement continuous improvement... and Biomedical Laboratory (BMBL) guidelines Knowledgeable in FDA, EMA, GxP and ICH regulatory requirements. Good working knowledge...
for each member. o Assess and evaluate member’s initial needs through the EMA screening tool. o Educate members about Case...-site programs to ensure quality standards are met. o Abide by NASW code of ethics, HIPPA and Atlanta EMA Case Management...
methodologies Extensive knowledge of GMP, ICH and FDA/EMA regulations Excellent technical writing skills including but not limited...
methodologies Extensive knowledge of GMP, ICH and FDA/EMA regulations Excellent technical writing skills including but not limited...
for clinical trial disclosure rules (EMA Policy 0070, Health Canada, USFDA) such as FDAAA 801, EudraCT for Data Sharing. Subject...