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

UK Biocentre

Senior Quality  Officer

Quality Officer

Global Access Dx (GADx) (formerly Mologic)

•	Contributing to the development and continuous improvement of the Quality Management System (QMS) of the company.
•	Developing and monitoring the effectiveness of the staff training matrix and helping define individual training requirements.
•	Raising and resolving CAPAs to identify non-compliances and potential non-compliance. Reporting and communicating these and advising on the most effective way of addressing them.
•	Conducting internal audits to ensure compliance with the QMS and all applicable standards.
•	Contributing to support and ensuring compliance is maintained through the change control procedure.
•	Approving the release of intermediate materials and finished product.
•	Experience in working in an ISO 13485:2016 and GMP-regulated environment including experience in design control processes.

Quality Assurance Officer

•	Processing COVID-19 samples in accordance with UKAS accredited laboratory standards ISO 9001:2015, ISO15189:2012 and ISO17025:2019.
•	Having significant experience working in a wide variety of roles involved in the detection of SARS-COV-2 in human samples using the automated ePCR technique.
•	Performing validations of reagents and creating and troubleshooting different protocols. 
•	Following GDocP and GLP guidelines.
•	Assisting the Section Manager to review and create SOPs and recording data on LIMS.
•	Operating Nexar, Hydrocycle and Araya equipment.
•	Ensuring Health and Safety procedures are followed correctly as a Fire Marshall. 
•	Using the Tecan and Hamilton automated liquid handling robot systems and qPCR system.

Laboratory Operator

 JD Wetherspoon

•	Prepare, cook and present food, quickly and efficiently, meeting the standards
•	Assist in ensuring accurate food-ordering and stocking levels
•	Assist in keeping wastage to a minimum, through correct product measurement
•	Use the food development plan to improve sales and profitability of the pub

Kitchen Team Leader

Amazon UK

•	Monitoring and providing reports on Key Performance Indicators (KPIs) regarding accuracy and integrity of Quality and Inventory transactions 
•	Analysing defect data and developing action plans to reduce and eliminate causes 
•	Root cause investigation of defects
•	Outbound/ Inbound experience
•	Instructor
•	Data collection and Problem solving
•	Participating in continuous improvement project

ICQA Associate

CEVA SANTE ANIMALE

I was focusing on becoming familiar with specific products and production processes related to Animal Health Vaccine Production in both facilities (CEVA-Phylaxia, CEVA-Biomune). I was learning how to review and analyse the vaccine production processes and how to use the technology to optimize the virus and bacterial production processes as well as how to best coordinate among facilities worldwide to meet customer demand.

•	Working within an accredited (ISO13485) industrial production aseptic environment
•	Capacity Utilization and Improvement Opportunities
•	Maintain and standardize Good Manufacturing Practices
•	Sourcing New Technologies
•	Technology transfer
•	Commissioning, Validating, and Implementation 
•	Optimization Project Management
•	Lean manufacturing

Future Production Manager

Teva Pharmaceuticals

•	Working in the Division of Active Pharmaceutical Ingredients, Department of Biotechnological R&D
•	Fungal (Basidiomycetes, Ascomycetes) and bacterial cell culture growing, strain maintenance
•	Mutagenesis (chemical, physical)
•	HTS screening
•	Media optimization
•	Screening methods (random, rational)
•	Transformation of bacteria
•	Transformation and electroporation of fungi
•	DNA, RNA manipulation (nucleid acid isolation, quantitative and semi-quantitative RT-PCR)
•	Coordination of laboratory work using small-scale fermenters according to GLP requirements
•	Participation in development projects mainly bacterial and fungal
•	Coordination of pilot-scale production according to GMP requirements
•	Coordination of maintenance work in the pilot plant
•	Equipment Qualification Processes
•	Responsibility of training in pilot plant

Research And Development Engineer

Vienna University of Technology

•	Working on a PhD in the Gene Technology and Applied Biochemistry department of the Institute of Chemical Engineering

Project assistant

I am an experienced quality-minded person with over 7 years in the pharmaceutical sector and more recently in the medical device sector. I am a motivated, reliable person, with a professional approach. I have a wide range of skills and experience working efficiently in various demanding environments. I am enthusiastic about pursuing a career in life sciences and diagnostics. After achieving my MSc in Molecular Biology, I have been working in various industrial environments. My employment and educational background have supplied me with the tools to manage a wide range of laboratory-based work requirements and situations.

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The Battle

Mohammad Naiem Salem

Marianna Mikus MSc, PCQI

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