, FDA, and EMA regulations for raw materials and relevant ICH, ISO, and USP/EU/JP compendial guidance. Experience...
Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced, ASNT NDT Level II, III, and ASQ...
mitigation (FDA, EMA). Support inspection readiness and regulatory interactions (Food and Drug Administration, European...
(FDA, EMA, Annex 1). Ability to interpret URS, P&IDs, batch records, and qualification protocols;comfortable...
, and execution strategy. Stay current on evolving global regulations (ICH-GCP, FDA, EMA, GDPR, local requirements) and adapt... working knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements for clinical trial initiation. Proven experience...
requirements (FDA, EMA, ISO 14155, GCP, GDPR). Excellent organizational, leadership, and communication skills. Preferred...
technical contact during regulatory inspections (FDA, EMA, etc.) and internal quality/HSE audits for visual inspection...
reporting to regulatory authorities (e.g., FDA, EMA, Health Canada, MHRA). Monitor recall effectiveness and conduct recall...
Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced, ASNT NDT Level II, III, and ASQ...
this experience will not be considered. Experience utilizing Modernizing Medicine / EMA Electronic Medical Record (EMR) highly...