Moataz Helmy
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Personal Information
Organization / Workplace
Egypt Egypt
Occupation
Certified Q.A. Manager, CMQ/OE at Pharmaceutical Industries
Industry
Medical / Health Care / Pharmaceuticals
About
•Assure execution of all GxP compliance systems/activities required to be implemented. •Continuous monitoring and data trending of all GMP relevant areas, including KPIs, reports to management and derived action plans. •Ensuring overall regulatory compliance and business continuity. •Expert in analytical method validation, cleaning validation, and stability management. •Assure implementation of product quality reviews (APQR) reports enabling process improvement. •Responsible for the handling of Complaints, Counterfeits, and Recalls. •Manage quality agreements for contractors. •Performing audits as lead auditor assuring report in place, the action plan in place and follow up.
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HVAC for non sterile dosage form

12 years ago • 10844 Views
Personal Information
Organization / Workplace
Egypt Egypt
Occupation
Certified Q.A. Manager, CMQ/OE at Pharmaceutical Industries
Industry
Medical / Health Care / Pharmaceuticals
About
•Assure execution of all GxP compliance systems/activities required to be implemented. •Continuous monitoring and data trending of all GMP relevant areas, including KPIs, reports to management and derived action plans. •Ensuring overall regulatory compliance and business continuity. •Expert in analytical method validation, cleaning validation, and stability management. •Assure implementation of product quality reviews (APQR) reports enabling process improvement. •Responsible for the handling of Complaints, Counterfeits, and Recalls. •Manage quality agreements for contractors. •Performing audits as lead auditor assuring report in place, the action plan in place and follow up.