Labeling Manager
labeling Knowledge of labeling within a Therapeutic Area Knowledge of FDA, or EMA, or other international regulations...
labeling Knowledge of labeling within a Therapeutic Area Knowledge of FDA, or EMA, or other international regulations...
environment (ICH/Compendial/FDA and EMA). Responsibilities: Main focus: The Manager/Senior Manager of CMC QC will work... that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies. Method...
requirements (e.g., FDA, EMA) Experience with manufacturing processes such as lyophilization, crystallization, filtration...
, Lab Equipment Validation, quality system, Change Control, Deviation, CAPA, Asset Standardization, OEM, FDA, EMA, Auto Desk... within an FDA/EMA regulated environment. Auto Desk Fusion 360 or SolidWorks experience preferred. Experience in CAD design...
and external contract test lab operations is preferred. · Comprehensive knowledge of FDA and EMA regulations and experience in...
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...
. · Excellent time management skills · Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations · Able...
, CAPA, Asset Standardization, OEM, FDA, EMA, Auto Desk Fusion 360, SolidWorks, CAD Design, Equipment Validation Top Skills... and process equipment within an FDA/EMA regulated environment. • Auto Desk Fusion 360 or SolidWorks experience preferred...
or pharmaceutical industries. Experience supporting lab and process equipment within an FDA/EMA regulated environment. Auto Desk...
or pharmaceutical industries. Experience supporting lab and process equipment within an FDA/EMA regulated environment. Auto Desk...