Sahar Makram Elnanai
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Sahar Makram Elnanai Email & Phone Number

Quality and compliance Head at SAUDIBIO - سعودي بايو
Location: Cairo, Egypt 7 work roles 13 schools
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Current company
SAUDIBIO - سعودي بايو
Role
Quality and compliance Head
Location
Cairo, Egypt
Company size
135 employees

Who is Sahar Makram Elnanai? Overview

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Quick answer

Sahar Makram Elnanai is listed as Quality and compliance Head at SAUDIBIO - سعودي بايو, a with 135 employees, based in Cairo, Egypt. AeroLeads shows a matched LinkedIn profile for Sahar Makram Elnanai.

Sahar Makram Elnanai previously worked as Quality Assurance Manager at Global Napi Pharmaceuticals and Quality Assurance Manager at Pharco B International For Chemicals - Pbic. Sahar Makram Elnanai holds Bachelor Of Science - Bs, Pharmaceutical Sciences from King Saud University.

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SAUDIBIO - سعودي بايو

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Profile bio

About Sahar Makram Elnanai

Seasoned Quality Project Management Expert with over 30 years of experience in the pharmaceutical industry. I leverage my expertise to guide companies towards operational excellence, ensuring the highest quality standards across all aspects of production. My in-depth knowledge encompasses diverse dosage forms, including sterile, aseptic lyophilization, blow-fill-seal, dedicated Betalactam, and non-sterile processes. A passionate advocate for continuous improvement, I have a proven track record of establishing robust quality systems and seamlessly integrating them across large-scale operations. My commitment to quality is further underscored by my ASQ certification in Quality Management and Operational Excellence.

Listed skills include Temperature Mapping, Documentations, Equipment Qualification, Gmp, and 19 others.

Current workplace

Sahar Makram Elnanai's current company

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SAUDIBIO - سعودي بايو
Saudibio - سعودي بايو
Quality and compliance Head
Website
saudibio.com
Employees
135
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7 roles

Sahar Makram Elnanai work experience

A career timeline built from the work history available for this profile.

Quality Assurance Manager

Current
Global Napi Pharmaceuticals

Cairo Governorate, Egypt

• Led and managed quality audits (GMP/GDP) for sterile and aseptic manufacturing sites, effectively communicating findings to multinational contractors and regulatory agencies (Pfizer, Sanofi, GSK, EDA, SFDA, PIC/S, etc.)• Plan and ensure professional execution of International API manufacturers Inspection.as part of supplier qualification.• Identified areas of risk during audits and provided independent assessments on their impact.• Contributed to the development and implementation of a risk-based audit program for the site.• Supported the internal and external auditor qualification programs.• Served as a key member of the Site Risk Management Board, ensuring adherence to review procedures and effectiveness of mitigation plans.• Implemented and maintained a comprehensive risk management plan for processes.• Established and oversaw an in-process control (IPC) system to ensure quality is built into the product.• Managed the deviations and complaints handling system, ensuring proper investigation and resolution.• Played a key role in the Site Change Control Board, ensuring adherence to procedures and efficient risk-based impact assessments.• Planned, implemented, and monitored Annual Product Quality Review (APQR) processes, analyzing trends and identifying areas for improvement.• Reviewed and approved validation master plans, protocols, reports, calibration programs, and calibration plans.• Provided technical expertise for process validation, cleaning validation, equipment and utilities qualification programs.• Supported the validation of computerized equipment systems.• Authored and maintained technical documents related to quality assurance, validation, compliance, and other areas, ensuring compliance with current GMP regulations.• Developed and delivered specialized training presentations on various topics.• Compiled corrective and preventive action plans for regulatory and contractor audits.

Sep 2019 - Present
Team & coworkers

Colleagues at SAUDIBIO - سعودي بايو

Other employees you can reach at saudibio.com. View company contacts for 135 employees →

KK Khalid Khaldi Khalid Khaldi Colleague at Saudibio - سعودي بايوMecca, Makkah, Saudi Arabia View → BD Bong De Leon Bong De Leon Colleague at Saudibio - سعودي بايوRiyadh, Saudi Arabia View → AG Aby George Aby George Colleague at Saudibio - سعودي بايوRiyadh, Saudi Arabia View → MM Mansour Mansour Mansour Mansour Colleague at Saudibio - سعودي بايوJordan View → PR Public Relations Public Relations Colleague at Saudibio - سعودي بايوSaudi Arabia View → SA Shaheer Ali Shaheer Ali Colleague at Saudibio - سعودي بايوRiyadh, Saudi Arabia View → SI Shaiful Islam Shaiful Islam Colleague at Saudibio - سعودي بايوRiyadh, Saudi Arabia View → MS Maryam Siddique Maryam Siddique Colleague at Saudibio - سعودي بايوRiyadh, Saudi Arabia View → SA Sara Alhassan (Cipd L5 Candidate) Sara Alhassan (Cipd L5 Candidate) Colleague at Saudibio - سعودي بايوRiyadh, Saudi Arabia View → JH Jubran Harthi Jubran Harthi Colleague at Saudibio - سعودي بايوRiyadh, Saudi Arabia View →
13 education records

Sahar Makram Elnanai education

Certificate Of Attendence, Eca - Inspection Management

European Compliance Academy - Eca

Certified Manager Of Quality/Organizational Excellence, Awarded Certificate

American Society For Quality

Activities and Societies: American Society for Quality

Diploma, Total Quality Management

The American University In Cairo

Activities and Societies: 6 Sigma, quality management, project management, planning and ISO guidelines.

Certificate, Certified Corporate Trainer

The Canadian Center

Certified Lead Auditor, Iso 9001:2008 Series

Bureau Veritas

Certificate, Project Management Fundamentals

New Horizons

Certificate, Iso 14001:2001 & Ohsas 18001:2007 Requirements And Audit

Engineering Quality Experts

Certificate, Clean Room Technology

Pharma Mix

Certificate, Process And Cleaning Validation

Pharma Quatec

Diploma, Neuro Conditioning Dynamic

Canadian Center For Human Development
FAQ

Frequently asked questions about Sahar Makram Elnanai

Quick answers generated from the profile data available on this page.

What company does Sahar Makram Elnanai work for?

Sahar Makram Elnanai works for SAUDIBIO - سعودي بايو.

What is Sahar Makram Elnanai's role at SAUDIBIO - سعودي بايو?

Sahar Makram Elnanai is listed as Quality and compliance Head at SAUDIBIO - سعودي بايو.

Where is Sahar Makram Elnanai based?

Sahar Makram Elnanai is based in Cairo, Egypt while working with SAUDIBIO - سعودي بايو.

What companies has Sahar Makram Elnanai worked for?

Sahar Makram Elnanai has worked for Saudibio - سعودي بايو, Global Napi Pharmaceuticals, Pharco B International For Chemicals - Pbic, Pharco B International, and European Egyptian Pharmaceutical Industry.

Who are Sahar Makram Elnanai's colleagues at SAUDIBIO - سعودي بايو?

Sahar Makram Elnanai's colleagues at SAUDIBIO - سعودي بايو include Khalid Khaldi, Bong De Leon, Aby George, Mansour Mansour, and Public Relations.

How can I contact Sahar Makram Elnanai?

You can use AeroLeads to view verified contact signals for Sahar Makram Elnanai at SAUDIBIO - سعودي بايو, including work email, phone, and LinkedIn data when available.

What schools did Sahar Makram Elnanai attend?

Sahar Makram Elnanai holds Bachelor Of Science - Bs, Pharmaceutical Sciences from King Saud University.

What skills is Sahar Makram Elnanai known for?

Sahar Makram Elnanai is listed with skills including Temperature Mapping, Documentations, Equipment Qualification, Gmp, Process Validation, Change Control, Validation, and Iso 9000.

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