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

Qualfon

Asesor académico

Working as a insurance adjuster doing claims activities like payments, price protection investigation, travel investigation, sinister etc.

Claim adjuster

Novartis

1.- Experience as chemical support and PC (Physical Chemical) lab analyst at Novartis pharmaceutical QC (Quality Control) laboratory doing the following activities: 

1.1.-As a analyst:
1.1.1.- I have experience to implement one analytical method (Votrient tablet) according to the Pharmacopeia (FEUM, Ph. Eur. and USP) requierements and also I was working with analytical Method Validation for Votrient finished pharmaceutical product doing the following activities (to release batch from other country to Mexico country):
1.1.1.1.- Execute the analysis according the monograph analytical, SOP, WI (work instruction) and WP (work procedure) requirements 
1.1.1.2.-. I have experience to know how analyze the API and the root-cause (Ishikawa and DMAIC) to resolve the Votrient problem defect (Tablet) analytical method using different kind of protocols, technology and analytic Method transfer to develop the method and resolve that problem.   

1.2.- As a chemist support:
1.2.1.- Experience to manage GMP document using the Web Consumer GMP and ESOPs D2 repository tool. 
1.2.2.- I was using the Potentiometer (linked with laboratory management system LabX) for different kind of analysis. 
1.2.3.- Use and verification (doing tickets) of microbalances, analytical balances and granular balances. 
1.2.4.- I was using the Dissolutor system doing generation of ticket for the following activites: 
1.2.4.1.- mechanical Calibration of the Dissolutor system (adjust stems of baskets, pallets). 
1.2.4.2.- complete diagnosis of the Dissolutor system doing measurement of the temperature of the tub and glasses. 
1.2.5.- Management of weight and volumetric instruments, hazardous waste risk management.

Quality Control Analyst

Development Management & Consulting Group, Inc. (DMCG)

I was working as a Record Management Agent at MSD (Merck Sharp and Dohme) doing activities as a Validation Engineer and CSV in laboratory and production equipment following guidelines as dictated by FDA regulations making the following activities:  
•	According to the SDLC methodology(retirement), i was preparing formats and instructions to analyze data and its documentation of systems related to laboratory and production equipment, this with the objective of evaluating its validated status with standards (data integrity resource) for MSD (animal (Santa Clara) and human (Xochimilco) health) as an engineer at DMCG. 
•	Validation of electronic documents (spreadsheet, final reports, electronic audit log), e-signatures , electronic records and softwares (standalone and client server) according as a said FDA (CFR 211.11) and Mexican (NOM-059-SSA1-2015) requirement of assets from:
	Systems of Coppertone production (cosmetic production), 
	Undra (special packing equipment), 
	Systems of Chemical and biological QC laboratory:
	Particle Counter Master Size,
	KF titrator, TIAMO
	UV-VIS, 
	All Fenbendazole production system (process involved: Cyanourethane, Destillation, cyclization, etc.) all that kind of system had reactors, tanks, valvule, etc. and utilities whose a software LabVIEW was controlled and as a CSV like me was needed to validate, example Systems, programs and electronic data. 

•	Audit all intern GMP equipment and documents as dictated global procedure regarding data integrity topic. I was working with the following documents:
	Logbooks document Cleaning and use.
	Maintenance and calibrations (internal and external origin calibration)
	Preventive, corrective and predictive maintenance 
	SDLC (System Development Life Cycle) 
	Equipment Qualifications (IQ, OQ, PQ) 
	Spreadsheet and processes Validation 
	PMD (Performance Monitoring Plan) 
	SOP (Standard Operating Procedure) 
	Management of a GMP repository for procedure histories called MIDAS

Record Management 

UIS Unidad de Investigación en Salud

A) Proyecto de investigación de sanidad para certificar un producto de harina de trigo que esta modificada y hecha por una empresa para personas Celiacas (libres de gluten).

B) Proyecto de producción de intermediarios farmacéuticos por métodos metalúrgicos.

C) Apoyo en el desarrollo de un biofarmaco para la Esclerosis multiple, realizando las siguientes funciones:
1.-Fui lider del proyecto para implementar una técnica de investigación para ver el efecto de los oligodendrocitos con la proteína Sonic Hedgehog (Shh) 
2.- Experiencia en realizar y coordinar las siguientes actividades capacitado por la Universidad del Paso Tx. (UTEP):
2.1.- Cultivo y tratamiento celular de hibridoma eucarionte (MO3.13, fusión de un oligodendrocito y un osteosarcoma)
2.2..- Criopreservar células eucarionte
2.3.- Caracterización genotipica y fenotipica de células eucariontes con tratamiento utilizando microscopia, ELISA, PCR en tiempo real.

D) Detección y Cuantificación del 1,8 cineol en plasma

Management buy out (MBO) en innovación y desarrollo

Laboratorio propio 

Me dedico a la elaboración de equipos para la industria química, biológica, medicina y otras áreas de la salud y la industria, así como la fabricación de productos químicos farmacéuticos, esto con el fin de desarrollar un vínculo desde de la ciencia básica a la tecnología, mi experiencias en específico es:
• Sistemas de control termoeléctricas (Equipamiento básico y especializado, patente en proceso: termociclador). 
• Realización de sistemas quimico-optico (espectrofotómetro, modelo de utilidad en proceso).
• Medidas por ppm de cualquier gas por sensores y cristalería de laboratorio.
• Matemáticas aplicadas en las áreas de ingeniería (teoría de control, reconocimiento de patrones, etc.) como además de la biología (Bioinformática: NGS, microarreglos, redes metabólicas, PDB, etc.) y la química (modelado de moléculas, etc.)
• Diseño y simulación y construcción de maquinado, equipos o robots para la aplicación en la industria maquiladora, medicina, Química, etc. 
• Amplia experiencia en la aplicación y estudios especializados en las buenas prácticas de cualquier industria de manufactura como también en las buenas practicas clinicas.

Investigador independiente

Universidad Autónoma Metropolitana, Xochimilco, Universidad Autónoma de Ciudad Juárez

Aislamiento de bacterias.
• Aplicaciones de técnicas bioquímicas para la identificación de género y especie de cualquier bacteria.
• Aplicación de la técnica para identificar resistencia a antibióticos llamada concentración mínima inhibitoria (MIC) y aplicación de antibiogramas Kirby Bauer.
• Aplicación de técnicas moleculares (PCR, extracción de ADN) en bacterias para identificar género, especie y sub-especie, identificación de genes involucrados en factores de virulencia o de resistencia antimicrobiana.
• Experiencia en la identificación de clonas de interés epidemiológico por medio de la epidemiología molecular (identificación y caracterización del gen spa y genomas completos para la aplicación de secuenciación y PFGE)

Técnico de laboratorio

Universidad Autónoma de Durango

Profesor en los campos de Genética, Embriología, Epidemiología y Química por honorarios

Profesor

Instituto Mexicano del Seguro Social

Dirigir un curso para personal del IMSS sobre bioseguridad en laboratorios clínicos.

Consejero

Biodist Servicios Corporativos S.A. de C.V.

Backup de planos arquitectonicos y otros archivos de proyectos especiales.

Call center para agentes e ventas.

Fichas tecnicas de Equipos, kits, e insertos para laboratorios de clínico, Biología Molecular, forense, sanidad animal, etc. para la pagina web de la empresa.

Asistente de la Dirección Científica para la elaboración de primeros diseños. La experiencia está en la elaboración de un laboratorio de abejas, banco de huesos, laboratorio de implantes, laboratorio de diagnostico molecular, clínico, sanidad animal como vegetal, laboratorios especializados como forense, Infectología, crónico degenerativas, salud publica, Check-Up Genético, Huella genética, cáncer, Farmacogenómica y Oncohematológicas. Manejo del Software Microsoft Visio para la planeación de procesos (diagramas de flujos) para cualquier puesto de ventas y científico para ISO 9001:2008.

Búsqueda bibliográfica de artículos de investigación, análisis bioinformatico de oligonucleótidos que consta de análisis termodinámicos y análisis de especificidad (blast), como además realización de diseños por scripts de primers y sondas in silico e in novo, , y como ultimo el análisis globales o totales bioinformaticas en bases de datos o artículos sobre marcadores moleculares en resistencia a antibiótico de agentes infecciosos, metabolismo de fármacos (Farmacogenómica), cáncer, relaciones de kits, enfermedad- gen y sus mutaciones, enfermedades congénitas, etc. Como comienzo de información para los asesores científicos en amplibio S.A. de C.V., diseño de microarreglos de baja densidad para influenza aviar para las empresas avícolas (ejemplo: bachoco, sagarpa, etc.), la empresa me rento un sistema para analizar datos OMICS en el contexto de vías metabólicas, gene ontology y redes neuronales metabólicos, todo el procedimiento bioinformático y de búsqueda bibliográfica fue revisado y validado por la ISO 9001:2008.

Soporte en Aplicaciones Moleculares

My professional objective is to be an outstanding Chemist, in a solid and reliable company. I have worked in different companies and areas, where I have learned different research methods, Validation, laboratory techniques, sales strategies, etc. And now I am looking for a position where I can exploit all my abilities to achieve my professional goals. I am very observant, proactive, I have strong interpersonal skills and adaptability, which helps me find solutions that will result in the achievement of goals.

taplio

The Battle

Mohammad Naiem Salem

Miguel Quiñones

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