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

PT. Mulia Farma Suci

Audit Internal
GAP Analysis
Audit External
Kualifikasi Pemasok
Recall & Mocked Up Recall
Complaint, Deviation, Change Management, QRM
Ikut serta dalam update sertifikat CPOB, CPOTB, & FasBer
PJ Pharmacovigillance II

GMP Compliance Spv

PT. Gracia Pharmindo

-Review BR and CoA
-Helping re-certification for ISO QMS 9001 : 2015
-Do coordination for CPOTB's new certification process for traditional medicine (OT) line
-Do coordination for TKDN
-Do coordination for CPOB's new certification for small volume parenteral (SVP) line
-Do coordination for ISO 9001 from URS
-Make gap analysis of existing product and NIE
-Joined SJH's team
-Joined 5S's team
-Joined as APJ Quality Assurance Traditional Medicine
-Joined as representative in charge of pharmacovigilance
-Helping QA Manager's function

Assistant Manager QA

PT. Imedco Djaja

APJ Kosmetik:
Take decision to release or reject cosmetic finished product for sale taking inti account related factors
Informing BPOM of a recall of cosmetic products due to defecta or suspected quality defects
Make a commitment letter, statement letter, & quality documents needed to fulfill cosmetic registration requirements
Provide a follow-up response to letter issued by BPOM related to quality of cosmetic products
Dia position on the release of cosmetic products if needed
Give approval to extermination plan
Coordinate with QA Dept Head

Apoteker Penanggung Jawab Kosmetik

Qualification (machine, room, facility), Calibration, Temperature Mapping, Spreadsheet Validation, Shipping Validation, and PQR

Quality Assurance Specialist

PT. CKD OTTO PHARMACEUTICALS

Handling calibration machine & HVAC Qualification
Execute & Coordinate Validation & Qualification
Prepare & review protocol validation & qualification
Prepare & review report validation & qualification
Making water monitoring and environmental monitoring annually report

Quality Assurance Supervisor

Unit 5, Biologicals Plant, PT. Sanbe Farma

Has many experiences on making VMP, SOP, protocol, report, and other related documents and executing of Validation activities at Biologicals Plant, Unit 5, PT. Sanbe Farma. Also has experience on making of QRM and CAPA documents and conducting review of BMR of media fill.

Validation Engineer

Unit 4, Oncology Plant, PT. Sanbe Farma

Has many experiences on making VMP, SOP, protocol, report, and other related documents and executing of Validation activities at Oncology Plant, Unit 4, PT. Sanbe Farma. Also conducting review of BMR of media fill.

PT. IFARS Pharmaceutical Laboratories

Validation internship : for making SOP, report of process validation and analytical method validation
RnD internship : for making QbD document

Student Internship: QA (Validation) & RnD (QbD)

A professional with 7 years of work experiences in the field of quality assurance in the pharmaceutical industry, who has developed skills in validation, qualification, calibration, and GMP Compliance.
Experiences of Apoteker Penanggung Jawab Pedagang Besar Kosmetika : responsible of cosmetics distribution

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Mohammad Naiem Salem

Erlita Prastika Dewi

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