Dynamic Quality and Regulatory Affairs Professional with over 8 years of experience in the pharmaceutical industry, demonstrating a strong understanding of drug compliance and regulatory standards. Committed to ensuring the quality, safety, and efficacy of pharmaceuticals to protect public health. Proficient in Microsoft Office Suite, Adobe Reader, and regulatory submissions, with a proven ability to compile dossiers and effectively address regulatory queries. Expertise includes exceptional communication skills, quality management systems (QMS), specifications, standard operating procedures (SOPs), market complaints, corrective and preventive actions (CAPA), change controls, deviations, validation processes, and out-of-specification (OOS) investigations.
Regulatory compliance
CAPA management
Technical document review
SOP development
Product dossier preparation
Internal audits
Quality management system (QMS)
Documentation control
Regulatory agency liaison
Batch record review
Stability data review
Hands on microsoft office
Manufacturing process validation