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...
, EMA). Project Management Professional (PMP) certification with proven success with external partnerships...
; communicate any issues or risks proactively. Ensures compliance with FDA, EMA, and global regulatory requirements; assures the...
requirements (e.g., FDA, EMA) Experience with manufacturing processes such as lyophilization, crystallization, filtration...
responders and ecological momentary assessment (EMA) methodologies. Data Analysis, Manuscript Preparation, & Writing: Develops...
, 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...
requirements (FDA, EMA, ICH, etc.) and industry standards (GMP, GLP, GAMP, etc.) related to CQV. Experience with risk...
as well as general industry (ICH, USP, etc.) and health authority (FDA, EMA, Health Canada, MHRA, etc.) requirements for advanced cell...
and competitive data is accurate, scientifically sound and credible. Stay current with FDA and EMA regulations and guidance...
(s). They will adhere to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, GCP...