Egyptian Drug Authority

- Developing policies and strategies to support the local pharmaceutical industry.
- Development and Improvement project for a new Auditing System.
- I have been the project manager responsible for the accreditation of the inspection department from the E.G.A.C. for ISO/IEC 17020:2012 -Conformity assessment - Requirements for the operation of various types of bodies performing inspection.
- I was a member of the team responsible for WHO Global Benchmarking Tool (cGBT) assessment of Indicator 06. Regulatory Inspection (RI).


Skills: 
· Operations Management
-Project Management Professional 
-Strategic Planning 
· Corrective and Preventive Action (CAPA) · 
· Business Process Improvement | Quality Improvement ·
· Risk Management | Failure modes effects analysis (FMEA) | Failure mode, effects and criticality analysis (FMECA) | Hazard Analysis and Critical Control Points (HACCP)
· Team Leadership
· Decision-Making
. Problem Solving

Local Pharmaceutical Industry Development Unit Manager

Some of the tasks that I perform are:
- Conduct and report audits of pharmaceutical facilities, processes, systems, and documentation.
Evaluate the compliance of the audited areas with the applicable GMP regulations, guidelines, and standards.
-Identify and communicate any non-conformities, risks, or opportunities for improvement.
-Follow up on the implementation of corrective and preventive actions (CAPAs) resulting from the audits.
-Mentor and train other auditors or quality personnel on GMP auditing techniques and best practices.
-Maintain and update the audit records, schedules, and databases.

Skills: 
Knowledge of the Good Manufacturing Practice (GMP) regulations, guidelines, and standards applicable to the pharmaceutical sector, such as WHO, FDA (21 Code of Federal Regulations ), EMA, ICH, PIC/s, etc.
· Quality System 
· Operations Management
· Quality Auditing 
· Corrective and Preventive Action (CAPA) · 
· Business Process Improvement | Quality Improvement ·
· Risk Management | Failure modes effects analysis (FMEA) | Failure mode, effects and criticality analysis (FMECA) | Hazard Analysis and Critical Control Points (HACCP)
· Vendor Management
 · Document Management · Standard Operating Procedure (SOP) 
· Data Analysis · Microsoft Project · Microsoft Word 
· Team Leadership
· Decision-Making

Pharmaceutical GMP/ GSDP Lead Inspector/ Auditor 

→ Auditing of the Egyptian Active pharmaceutical ingredient API and finished pharmaceutical product (FPP) Manufacturers to assure their compliance with cGMP. 
→ Quality Assurance Documentation Review as Marketing Authorization and, Standard Operating Procedure (SOP) and others.
→ Sampling Products and Raw Materials for analysis in Egyptian Drug Authority Laboratories CADC.
→Approve Batch Production Record BPR for UPA and Market Release.

Pharmaceutical Factories Inspection Process Improvement
→ Team member of Improvement Project for the inspection directorate.
→ Prepare the Improvement Project Action Plan.

Audit Unit
→Prepare Audit and Follow up Plan.
→Issues and review the GMP certificate.
Skills: Quality Auditing as per 21 Code of Federal Regulations Part 210, 211, 820 | Quality Management  | Good Manufacturing Practice (GMP)
 Project Management Professional   Strategic Planning
 Ensuring compliance with GxP and regulatory requirements Risk Assessment based 
- Create, Review, and/or approve procedures, Master Batch Records, and any other relevant GMP documentation as per WHO Quality, ISO Standards 9001:2015, ISO 13485, and 21 CFR 820.
- Experienced with Qualification and Validation Plans, Activities, and Reports.
- Conducting internal and External audits, as Supplier site Audit to determine compliance with GMP/QMS and identify areas for continuous improvement.
- Review and Approval of Change Controls, Deviation, investigation, and Implementation of Corrective Action Preventative Actions (CAPA) management.
in GMP regulated Environments including Sterile /Non-Sterile settings such as pharmaceuticals / Biologicals/ medical devices/ Dietary Supplements

Pharmaceutical GMP Auditor & Inspector | Quality Auditing | Inspection Process Improvement

* Audit Raw material Stores and API Manufacturers to assure their compliance with GMP, GSP.
* key achievements as Section Head Assistant
1- Participate in the Planning and implementation of new systems and procedures for the new section (Raw Materials Inspection Department); as well as in the monitoring, controlling, and evaluation of processes; in compliance with existing policies.
2-Assist in the planning of the continuous improvement projects for API and Finished Product manufacturers as well as Stores.
3- Managed a team of 5 inspectors to deliver monthly business targets. and achieve their relevant duties.

Impact
- Development of (QMS procedures for the new section (Raw Materials Inspection Department); and KPI for  the monitoring, controlling, and evaluation of processes; in compliance with existing policies.)
-Modified customer service support system to reduce complaints by 25%.
Skills
Research and Development (R&D)
Communication
Teamwork
Product Development
Laboratory Skills
Lean Manufacturing

Raw Material Inspection, Section Head Assistant

→Ensure that all dietary supplement products adhere to science-based public standards for identity, strength, quality, and purity. and also
→Helps keep dietary supplements that are tainted with drugs and drug analogs off the market.
- Review, and/or approve procedures, Master Batch Records, and any other relevant GMP documentation as per WHO Quality, ISO Standards 9001:2015, and 21 CFR 820.
 - Conducting internal and External audits, such as Supplier site Audits to determine compliance with GMDP/GSP &QMS and identify areas for continuous improvement. 
- Review and Approval of Change Controls, Deviation, investigation, and Implementation of Corrective Action Preventative Actions (CAPA) management.
→ Sampling Products and Raw Materials for analysis in NODCAR Laboratories.
→ Approve Batch Production Record BPR for Market Release.

Dietary Supplement Inspector | Batch Record Reviewer for Approvals 

Upwork

• Managed a team of to deliver a new QMS System 
• Modified customer Quality system to reduce NCR by 20%.
• Modified customer service support system to reduce complaints by 10%.
Awards 🏅
• Received recognition for completing 20+ Successful projects with 5🌟 stars feedback, and for being customer focused in Solving their Problem.
✨My LinkedIn Page has 2.5 K+ Followers, and my Content has reached 1.25 M+ Impressions in 50 days.
** Ready to deliver;
-Pharmaceutical Quality System (PQS) & GMP FDA & European EMA Compliance | 
-Vendor Management / Supplier Qualification | 
-Validation [Process Validation, Cleaning Validation & Computer System Validation CSV]

Quality Management | Pharmaceutical Industry| FDA Regulatory Affairs| GxP Expert

Supplier Audit Program Manager-QHSE & Supplier Audit - On-demand Custom Instructor-led (in-person and virtually)

🔝Skills Used : 
Good Manufacturing Practice (GMP) & Quality Auditing 
Project Management Professional 
Supply Chain Management
Total Quality Management (TQM) Microsoft Project
Operations Management · Business Process Improvement · Operational Excellence 
Strategic Planning · Data Analysis · Business Strategy · Competitive Strategies  
Team Leadership · Public Speaking Decision-Making  
Training & Development · Team Management · Train the Trainer

Supplier Audit Program Manager-QHSE & Supplier Audit-On-demand Instructor-led (in-person virtually)

cGMP On-demand Custom Instructor-led (in-person and virtually) for regulatory Variation.

🔝Skills Used  in the Project : 
Good Manufacturing Practice (GMP) & Quality Auditing 
Project Management Professional 
Total Quality Management (TQM) & Supply Chain Management
Operations Management · Business Process Improvement · Operational Excellence 
Strategic Planning · Data Analysis · Business Strategy · Competitive Strategies  
Team Leadership · Public Speaking Decision-Making  
Training & Development · Team Management · Train the Trainer

cGMP On-demand Custom Instructor-led (in-person and virtually)

Bassem Tharwat Pharmacy

- Helping patients and the public, through assessing their conditions, and making
decisions about which medicines they should take.
- Offering patients advice and practical help in keeping healthy.
- Preparation of OTC Formulas.
- Order the required supplies for the pharmacy from Drug, Cosmetics, Devices.

Community Pharmacist

Egyptian Armed Forces

Officer  at The Medical Branch of Supply Chain Organization

As the Manager of the Local Pharmaceutical Industry Development Unit at the Egyptian Drug Authority, 
I am passionate about supporting and enhancing the local pharmaceutical industry. I develop and implement policies and strategies to ensure the quality, safety, and efficacy of pharmaceutical products, and to foster innovation and competitiveness in the sector.

With 8+ years of experience in the pharmaceutical industry, I have led and conducted comprehensive audits of pharmaceutical facilities and processes, upholding the highest quality standards and ensuring regulatory compliance with international standards (WHO, FDA, EMA). 
I have also managed and mitigated risks, reduced non-conformity rates by 80%, and improved the auditing system through process improvement methodologies (Lean, Six Sigma) and data analysis. Additionally, I have mentored and trained other auditors and quality personnel on GMP auditing techniques and best practices.

I have been the project manager responsible for the accreditation of the inspection department from the E.G.A.C. for ISO/IEC 17020:2012 -Conformity assessment - Requirements for the operation of various types of bodies performing inspection.
I was a team member responsible for the WHO Global Benchmarking Tool (cGBT) assessment of Indicator 06. Regulatory Inspection (RI)

I hold a Professional Diploma in Pharmaceutical Good Manufacturing Practice (GMP) from the Arab Academy for Science, Technology and Maritime Transport, and a bachelor's degree in Pharmaceutical Sciences from Al-Azhar University. 
I have also obtained certifications in the following:
✅Project management,
✅ Operational Excellence Work-Out and Kaizen Facilitator,
✅ Business Process Improvement,
✅productivity skills, 

I have been recognized as a LinkedIn Top Voice on the following collaborative articles:
✨ Good Manufacturing Practice
✨ Quality System
✨ Risk Management

My core competencies include quality management, risk management, project management, process improvement, data analysis, team leadership, communication, and training. 
I am fluent in English and Arabic and keenly interested in learning new skills and technologies. 
My goal is to contribute to the advancement and excellence of the pharmaceutical industry in gypt and beyond.
Mohammad Naiem

Mohammad Naiem Salem

Discovery Life Sciences

Sr. QA Specialist / Eastern Europe 

PharmaLex GmbH

• Development, management, monitoring and maintenance of GxP  relevant processes and procedures ; 
• Vendor management and qualification process / TPRM (Third Party Risk Management Process : development, implementation and maintenance of centralized Corporate Vendor Qualification / Management Process; GVMT Team - Interacts with cross functional Corporate worldwide located team members 
• Management of Deviations / Non-conformities, CAPA management :  QA leadership, maintenance, overview, approval and finalization of raised Corporate NC / CAPA. GxP compliance update of process / training (specific) of personnel 
• Change management - QA leadership, maintenance, overview, approval and finalization of raised Corporate CC ( change Controls). GxP compliance update of process; 
• Complaint management - GxP compliance update of process / QA leadership, maintenance, overview, approval and finalization of Complaint; 
• Quality risk management / risk assessment and other elements of Quality System - development and implementation of a risk based department / process oriented Risk Based strategy (FMEA) / IT GxP risk assessment as per ISO 27001 
• Management of inspection readiness activities, and support of client audits and inspections 
• GxP training and provision of work guidance regarding GxP Requirements - Specific trainings : Clean Deck , clear screen ; How to survive audits / inspections ; Handling of Nc and CAPA - department specific training 
• Leadership and/or participation in contractor/supplier audits - QA's involvement as part of Vendor's qualification process - GVMT Leadership 
• Compliance Committee QA's Support - Whistleblower tool / Policy; EcoVadis Certification; IT security. etc ; 
• IT projects QA's support - document review, approva

Senior GxP Manager

freelance

Quality Assurance Specialist

SMO Bulgaria Ltd / Clinical Trials

• Quality and compliance management of the clinical trials, conducted with respect to Standard Operating Procedures, applicable regulatory requirements (e.g. FDA, EU, ICH & country specific, and current industry standards and practices : ICH 6 / HIPPA, etc) 
• Company QMS SOPs creation, maintenance, update / training of employee ;
• CAPA (Corrective and Preventive Actions) : QA's leadership, maintenance, follow up, approval;  
• Change Control : QA's leadership, maintenance, follow up, approval;
• Quality Audits - Routine and non-routine quality assurance audits 
• Employee preparation for monitoring visits
• QA review of SD templates;

Quality Manager

Addisan Pharma LTD

• Drives continuous improvement efforts, ensuring the company and Quality Assurance stay updated on GMP requirements and trends through adequate training. 
• Oversees the preparation and approval of Standard Operating Procedures (SOPs) for quality-related activities. 
• Ensures regular and timely updating of all quality-related documents. 
• Oversees the conduction of required tests in compliance with approved specifications. 
• Manages the calibration and validation of equipment, systems, utilities, and methods used by Quality Control, aligning with internal policies. 
• Ensures all Quality Assurance activities are fully compliant with  approved procedures and adequately documented to reflect the current state of GMP. 
• Leads the development, implementation, maintenance, and follow-up of various elements of Pharma Quality Management Systems (QMS). - CAPA; Change control;  Risk Assessment;Supplier audits; Self-inspections; Process Validation; Equipment qualification; 
• Preparation for Inspections / inspections handlinging 
• Quality Manual update - describing Quality Management System of Pharmaceutical Quality System processes in scope of QMS. 
• Quality Management reviews for preliminary defined Quality Topics - Annually (preparation, coordination, organization, etc);
• Product Quality Review - approval

Quality Assurance Manager

Zobele Bulgaria, Part of Zobele Group

• Supplier's Quality Management improvement / homologation process Management : questionnaires, visits, action plans follow up, capability studies, PQC in supplier facilities. 
• IQC plans definition in the SAP system together with Quality manager. 
• Management of the NC related to raw materials : NC creation, maintenance, follow up in the SAP; management of the red area;
• Communication with he suppliers in coordination with procurement team, derogation, and following up actions with he suppliers.
• Annual supplier audit program Leadership / supplier improvement initiatives - as per Annual risk based Supplier auditing Program 
• Supplier performance periodical reporting : action plans from visits / improvement plans - creation, maintenance, follow up; 
• Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making

Supplier Quality Improvement Specialist

•	Organizing and managing  the Incoming QC inspectors to perform the IQC plans defined, managing the records and spec’s, golden samples from the customers;
•	Organizing and managing  the Production QC inspectors to perform the PQC plans defined;
•	Analyzing and measuring the processes, solving the issues and conducting the necessary training to the shift and line leaders regarding Quality
•	Managing  all the records and retained samples; managing the non-conformities related to finish or semi finish products;
•	Following up blocked materials and report weekly; managing the destruction or collection of the material;
•	Issue periodical reports about processes performance (NC, Qualitative/ Quantitative test results, Scrap, and KPI in general);
•	 Suppliers audits.

Quality Specialist

“Balkanpharma – Troyan” AD, Actavis Group

•	Organizing, preparing and coordinating
-	IQ, OQ, PQ of equipment and systems,
-	Process validation.
•	Taking participation in activities related with : 
-	Technological transfer;
•	Self-inspections implementation, 
•	Preparation and filling in MQS (Monthly Quality Statistic, Key Performance Indicators) and QQR (Quarterly Quality Reports), 
•	Site master Files preparation.

Process Validation Specialist

•	Introduction and observance of the pharmaceutical GMP principles;
•	Self-inspections implementation;
•	Basic GMP training;
•	Introduction of standard Operating Procedures, Manufacturing Regulations 
•	Site master Files preparation;
•	Participation in the Change Control system etc.

Current Good Manufacturing Practice Specialist

Experienced Quality Assurance Subject Matter Expert (SME) with over 21 years of successful career progression in the pharmaceutical industry. Proficient in leading expert teams, and organizational management across various sectors including Manufacturing, Clinical Trials, and Pharmacovigilance / QMC. 
Demonstrated expertise in Quality Management Systems (QMS) encompassing process development, implementation, and continuous improvement. Skilled in achieving GMP Certification, ISO 9001, and ISO 27001 Certification. Proficient with regulatory frameworks including HIPAA, 21 CFR Part 11, ICH R6, and GVP Module VI.
Proven track record in SOP creation, personnel training, and effective management of Change Control, Non-Conformance (NC), and Corrective and Preventive Action (CAPA) processes, Audit / inspections, Training, Vendor management and Qualification. Experienced in conducting Risk Assessments utilizing methodologies such as Failure Mode and Effects Analysis (FMEA), Fishbone Analysis, and 5 Why + 5 How approach.
Proficient in Value Stream Mapping to optimize processes, Vendor Management, and Qualification, as well as conducting Audits and inspections to ensure compliance with regulatory standards.
Extensive experience as a GxP Senior Manager (covering GMP, GCP, GVP, QMC, ISO 9001/27001, and 17025) adept at leading global, dispersed teams in remote settings.

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Mohammad Naiem Salem

Gergana Bezhanska

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