Ahmed MAHER ARAFA
Quality Specialist
10th Of Ramadan City - Sharqia
Summary
Healthcare Quality Specialist with over six years of experience in GAHAR and JCI accreditation, focused on patient safety and performance improvement. Proficient in JCI Hospital Standards, tracer methodology, internal and external audits, Root Cause Analysis (RCA), Key Performance Indicators (KPIs), and risk management. Holds a Master’s degree in Quality Management ( MQM ) and applies Lean quality tools to drive continuous improvement and enhance operational efficiency across healthcare settings.
Overview
7
7
years of professional experience
2
2
Languages
Work History
Quality Specialist
EGYPT Healthcare Authority - Ismailia Branch
11.2021 - Current
- Quality Specialist at Al-Areishya Family Medicine Center
Quality Team Member at Ismailia Medical Complex - Achieved GAHAR Accreditation at Ismailia Medical Complex, Al-Areishya Family Medicine Center and multiple PHCs (3-year accreditation)
- Ensure compliance to GAHAR Accreditation Standards and Patient Safety Requirements
- Analyze multi-source data to identify quality trends and drive continuous improvements.
- Drive a continuous improvement culture, achieving hospital-wide productivity gains and waste reduction using Lean quality tools (5S, PDCA, Kaizen, VSM).
- Enhance team performance through regular training and awareness sessions.
- Control Occurrence Variance Reports (OVRs), Conduct root cause analysis ( RCA ) following any non-conformance events , implement corrective actions & OVR classification.
- Utilize Self-Assessment Tool (SAT) to assess compliance and performance
- Develop and validate Key Performance Indicators (KPIs) using Excel and descriptive analysis.
- Execute internal and external quality audits across multiple healthcare centers in compliance with accreditation standards.
Quality Assurance Senior Specialist
Egyptian International Pharmaceuticals Co (EIPICO)
02.2021 - 09.2023
- Quality Assurance Senior Specialist at Sterile Areas Department (Hormone - Eye Drops):
- Manage CAPA management process through handling non-conformities
- Root Cause analysis using Quality tools & effective closure for GMP Internal & External audits
- Excute Quality risk management projects when needed.
- Work on issuing Policies according to USP, BP and other guidelines.
- Co-ordinate with other departments during internal & external visits.
Quality Assurance Specialist
Egyptian International Pharmaceuticals Co (EIPICO)
11.2019 - 02.2021
- Quality Assurance Specialist at Semi-Solid Department:
- Working on different Dosage Forms (Cream - Ointment - Suppository and Eye Ointment) on different lines: preparation, filling and packaging automatic lines.
- Approval of New Automatic Filling and Packaging lines for the company by ministry of health (MOH): IMA & SARONG 3 automatic filling and packaging lines.
- Revising & Archiving Batch Records and Assuring SOPs in all Departments
- Initiating deviation reports and making, corrective & preventive actions (CAPA) then making analysis of deviation reports.
Community Pharmacist
Walaa Eldeen Pharmacy
02.2019 - 10.2019
Education
Master of Science - MQM
Arab Academy For Science, Technology And Maritime Transport
Egypt 04.2001 -
Clinical Pharmacy Diploma - undefined
Faculty of Pharmacy - Zagazig University
Egypt08.2020
Bachelor's Degree in Pharmacy - undefined
Faculty of Pharmacy - Zagazig University
Egypt07.2018
Skills
Healthcare Accreditation (GAHAR, JCI)
ISO 9001:2015 Quality Management System (QMS)
Risk Management using FMEA & Patient Safety
Pharmaceutical Quality Assurance (QA) & Good Manufacturing Practices (GMP)
Root Cause Analysis (RCA)
Corrective and Preventive Actions (CAPA) Management & Follow-up
Internal & External Audits
Quality & System Inspection
Incident Reporting and Analysis (OVR)
Key Performance Indicators (KPIs) Analysis
SOPs Development, Review & Compliance
Data Cleaning & Visualization using Power BI
Microsoft Office (Excel, Word, PowerPoint)
Project Management & Quality Improvement
Accomplishments
- Cleaning and Process Validation
- Qualification of Sampling Points
- Thermal Validation of Autoclave
- Thermal Mapping
- Developing skills in data cleaning, visualization, and reporting using Power BI with a focus on data-driven decision making.
Qualification and Validation Course from ( Valor ) :
Digital Egypt Initiative – Ministry of Communications and Information Technology - Data Analysis & Power BI
Timeline
Quality Specialist
EGYPT Healthcare Authority - Ismailia Branch
11.2021 - Current
Quality Assurance Senior Specialist
Egyptian International Pharmaceuticals Co (EIPICO)
02.2021 - 09.2023
Quality Assurance Specialist
Egyptian International Pharmaceuticals Co (EIPICO)
11.2019 - 02.2021
Community Pharmacist
Walaa Eldeen Pharmacy
02.2019 - 10.2019
Master of Science - MQM
Arab Academy For Science, Technology And Maritime Transport
04.2001 -
Clinical Pharmacy Diploma - undefined
Faculty of Pharmacy - Zagazig University
Bachelor's Degree in Pharmacy - undefined
Faculty of Pharmacy - Zagazig University