regulatory requirements (FDA, EMA, etc.) Expertise in quality systems including: CAPA and deviation management Change control...
(GxP, FDA, EMA, etc.). Develop and review validation deliverables including Validation Plans, Risk Assessments, IQ, OQ, PQ...
cause analysis, regulatory communication, and CAPA tracking in alignment with global regulatory requirements (e.g., EMA..., with at least 2 years in Clinical Quality, GCP Compliance, or related role. Strong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA...
% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial...