Mr. Zelalem M. Sahile-Msc,CQA
Zelalem obtained his Bachler of Pharmacy, Bachler of Chemistry and Master of Science in Pharmaceutical Analysis and Quality Assurance of Medicines from Addisababa University in different periods and obtained his Master of business Administration (MBA) in project Management in from Lead Star College and is Certified Quality Auditor by the American Society of Quality (ASQ). Zelalem has extensive knowledge and experience in the QA/QC of medicines and medical devises at national and international level.
He is currently Chief of Party at United States Pharmacopeia/Promoting Quality of Medicine s plus(USP/PQM plus) program with more than 25 years of experience in Quality Assurance/Quality Control of Pharmaceuticals at different roles and responsibilities with Pharma industries, regulatory authorities and bioequivalence studies. Managed Quality Management System implementations and contributed in accreditation of different regulatory functions for lSO/IEC 17025:2017, lSO 4074, lSO9001,ISO/IEC1720:2012,WHO’s ML-3 and lSO14001.Trained couple of people on compendial and other testing techniques and also has intensive experience in compendial testing techniques like HPLC, Spectrophotometry, Minilab techniques, AAS, etc...Can manage different activities related to Quality Assurance of Medicines in multy disciplinary areas and countries. He also has experience in auditing testing laboratories for ISO/IEC17025,ISO/IEC15189 ,GCP,ISO14001,ISO 9001 and similar Quality Management system based international standards. Has produced a sustainable instrument calibration and Post marketing surveillance system in Ethiopia and supported regional initiatives like IGAD and WAHO/ECOWAS.He also supported the following countries in QA/QC of Medicines in general:
•Benin
•Burkinafaso
•Burma
•Ethiopia
•Ghana
•Kazakhstan
•Kenya
•Mali
•Madagascar
•Mozambique
•Rwanda
•Senegal
•SierrLeaon
•Uzbekistan
Work Experience:
1.Ethiopian Pharmaceutical Manufacturing(EPHARM):October 1999 to September 2010
Roles: Senior Laboartory analyst,head of Inprocess Quality Control/Quality Assurance
2.U S Pharmacopeia(USP)-October 2010 to March 2025-Implemented the Promoting Quality of Medicines programe which is funded by USAID an implemented by USP.
Roles:Regional senior technical advisor, regional Lead QA/QC Speciality, Chief of Party( Country Director).