Gamal Hakiem Email and Phone Number

Responsible for in- process checking – conducting quality audits as required to ensure compliance with cGMP and MOH guidelines with specification and proper documentation during production process• Participate in Management of Change Control.• Participate in Quality Risk Assessment& risk control for all activities.• Responsible for Handling of Deviation (Investigation, Root Cause Analysis (RCA), CAPA & CAPA Follow up).• Responsible for Batch Release & Annual Product Review(APR)• Member in Internal & External Audits Team.• Member in team for Handling Customer Complaints. • Review Validation & Qualification activities & prepare Validation & Qualification protocols such as (process validation protocols, clean validation protocols and analytical method validation protocol, equipment Qualification, HVAC Qualification, Utilities Qualification,…..) and supervise the operation to ensure everything is applied according to the protocols