Quality Management Specialist
Current•Leading and Managing the Quality Management System of the organization.-Creation and review (gap analysis) of local SOPs to ensure they are in conjunction with SFDA Guidelines and Policies.-Responsible for training employees on Standard Operating Procedures, SFDA Guidelines, Policies and Onboarding training for QMS.•Responsible for tracking Change Control and Deviation Management, ensuring on-time closure and maintaining the company’s KPIs.-Responsible for management and execution of internal and external Quality audits with CAPA tracking ensuring their implementation and closure.•Successfully managed SFDA’s inspection for Clinical Research Organization of Clinical Trials.•Responsible for Clinical Research Department for-Creation, review and update of SOPs for Clinical Trials-POC for clinical trial sponsors outside and inside of the KSA-Training on Clinical Research topics•Responsible for closely working and assisting the Pharmacovigilance department with respect to quality assurance.