with community utility service providers,police/fire/sheriff/EMS, and EMA departments in Columbus as well as nearbyjurisdictions...
with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
supporting regulatory agency (e.g., FDA, EMA, MHRA) inspections. Knowledge and experience in Good Laboratory Practice (GLP...
management permits consistent with the EMA. Maintains and creates files, records (File Action Forms), Accela records...
industry. Strong knowledge of cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, and ISO standards. Excellent written...
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...