Hi my name is Mohammad Naiem Salem
🏅I have 20+ Successful projects with 5 stars feedback 🌟🌟🌟🌟🌟
As the Manager of Local Pharmaceutical Industry Development Unit at 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 hold a Professional Diploma in Pharmaceutical Good Manufacturing Practice (GMP) from 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:
✅Project management,
✅ Operational Excellence Work-Out and Kaizen Facilitator,
✅ Business Process Improvement
✅productivity skills,
I have been recognized as a 𝐓𝐨𝐩 𝐕𝐨𝐢𝐜𝐞 on 𝐋𝐢𝐧𝐤𝐞𝐝𝐈𝐧 in the following collaborative articles:
✨ Good Manufacturing Practice
✨ Quality System
✨ Risk Management
My core competencies include quality management, quality risk management, project management, process improvement, data analysis, team leadership, communication, and training. I am fluent in English and Arabic and have a keen interest in learning new skills and technologies. My goal is to contribute to the advancement and excellence of the pharmaceutical industry in Egypt and beyond.
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)
✨My LinkedIn Page has 6K+ Followers, and my Content has reached 5 M+ Impressions.
🟡I will Train and assist you with FDA Compliance /Pharmaceutical Quality System (PQS) & GMP Audit | Vendor Management / Supplier Qualification | Validation [Process Validation & Computer System Validation CSV]
• Conduct 10 + GMP Training for functional areas supported and provides on-the-job training to new Quality Operations employees.
• Participated in 40+ regulatory inspections, and audits.
• Support and Review 500+ regulatory submissions of new products
• GMP certificate Issuance and renewals of more than 100 manufacturing Sites.
• Conducted internal system audits in areas of Quality Assurance, manufacturing, and Production, Formulation, Packaging, & Materials Management
• Performed 30+ supplier audits to assess compliance with regulatory requirements and industry standards.
• Executed risk assessments evaluating sourcing, system, and process challenges
• Authored, reviewed, and approved quality GMP documents.
• Interface with multiple levels of personnel and customer groups to assure drug product manufacturing operations remain in compliance with regulatory and corporate requirements.
• Enhanced GMP knowledge and interpersonal skills to support decisions, address risks, and mitigate challenges.
My Strong work professional skills: Quality Systems Development & Implementation, Change Control Management, Discrepancy Investigation, Product Life Cycle, CAPA, Document Control, Manufacturing, Risk Management, Validation, Internal & External Audits, Quality Agreements, Technology Transfer, Process Improvement, Project Management, Systems Integration, and Learning Management System.
I am self-motivated, a Continuous Learner, Decision Maker, and able to work independently as well as with a team,
I used to use work professional skills in solving problems, analyzing data, and implementing process improvement and Re-Engineering through Risk Assessment based thinking, Design Thinking, Lean Six Sigma tools and techniques, encouraging Teamwork, and Communication between the process owners.
I'm happy to provide support to you and your team in the development and Implementation of cGMP, quality processes & activities, and ensure readiness for FDA audit.
I’m always happy to connect with Pharmaceutical Industry professionals.
You can follow my work here ⬇️
I look forward to hearing from you!
Mohammad Naiem
Biotechnology Regulatory Affairs
