Director – Head of Quality Control Covington
. In-depth knowledge of industry standards and regulations related to quality control. Knowledge of FDA, EMA, CFDA, PDA...
. In-depth knowledge of industry standards and regulations related to quality control. Knowledge of FDA, EMA, CFDA, PDA...
Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced, ASNT NDT Level II, III, and ASQ...
labeling Knowledge of labeling within a Therapeutic Area Knowledge of FDA, or EMA, or other international regulations...
into the Central Nervous System (CNS penetrant) that has received Orphan Medicinal Product Designation from the EMA... Authorization Application (MAA) has been validated and is currently being reviewed by the EMA's Committee for Medicinal Products...
, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements Extensive experience in late-phase drug...
or equivalent in a Medical Device or FDA Regulated industry. Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR...
(e.g., ISO, FDA, EMA guidelines). Quality Management System: Establish and maintain an effective quality management system... Compliance: Ensure compliance with relevant regulatory agencies (such as ISO, FDA, EMA) and applicable guidelines, including Good...
Knowledge of FDA, or EMA, or other international regulations for labeling Understanding the impact of emerging trends... of labeling within a Therapeutic Area Knowledge of FDA, or EMA, or other international regulations for labeling Understanding...
Knowledge of FDA, or EMA, or other international regulations for labeling Understanding the impact of emerging trends... of labeling within a Therapeutic Area Knowledge of FDA, or EMA, or other international regulations for labeling Understanding...
Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...