Summary

Overview

Work History

Education

Skills

Software

Certification

Timeline

Mohamed Ahmed El-Menshawy

Professional Quality Manager

New Cairo, Cairo

Summary

Talented Manager with expert team leadership, planning and organizational skills built during successful career. Smoothly equip employees to independently handle daily functions and meet customer needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach.

Overview

12

12

years of professional experience

8

8

years of post-secondary education

7

7

Certifications

2

2

Languages

Work History

Operational Quality Manager

Marcyrl Pharmaceutical Industries

Obour

03.2021 - Current

Oversight Operational Quality including; Production, Quality Control, in process Control, Warehouses and Engineering Compliance
GMP Training Technical Support for production and Quality control
Technical Support and Troubleshooting of Production and Quality Control
Responsible for Batch record review team and Finished product Team
Responsible for Quality Assurance SAP activities team
Responsible for In process control team

New Products Quality Head

Marcyrl Pharmaceutical Industries

Obour

01.2019 - 02.2021

Review and Approve Pharmaceutical Development
Review and Approve Analytical Methods Development
Review and Approve Analytical Method Validation
Review and Approve Stability Studies
Review and Approve Comparative Dissolution Studies
Setting New products specifications
Evaluate New Suppliers (APIs, Critical exicipients)
CTD Module 3 process owner
Technology Transfer Process owner
Troubleshoot Regulatory concerns during registration phase

Compliance and Validation Assistant Manager

Julphar Saudi Arabia

Rabigh

04.2018 - 12.2018

Responsible for All Validation Activities including: Process Validation, Cleaning Validation, Annual product Quality review
Responsible for All Qualification activities including : Installation Qualification, Operational Qualification and Performance Qualification of Production machines, Laboratory equipments and Utilities
Risk assessment lead
Change Control lead
Product Recall lead
Supplier Qualification lead
Service Providers Qualification lead
Deviation and CAPA process owner
Technology transfer committee member
Responsible for CTD module 3
Acting as QA manager responsible for In Process Control and Documentation teams

Quality Assurance and Validation Manager

Riva Pharma

Free Zone, Nasr City

04.2016 - 03.2018

Manage All Quality assurance, Compliance and Validation Activities including : Documentation, Validation, In Process Control, Regulatory affairs, Internal Audit, Deviation management , Change Control management, Supplier Qualification & GMP training
Responsible For Batch Release

Quality Assurance Assistant Manager

RIVA pharma

Free Zone, Nasr City

01.2016 - 04.2016

Delegate QA Manager at all designation and activities including including : Documentation, Validation, In Process Control, Regulatory affairs, Internal Audit, Deviation management , Change Control management, Supplier Qualification & GMP training

Validation & Qualification Section Head

Rameda

Giza

08.2014 - 12.2015

Preparation & Execution of Validation Master Plan & Validation review reports
Taking a part in startup activities such as designing and qualification of instrument, Machinery and Utilities
Installation Qualification, Operational Qualification and Performance Qualification of Different machinery and Utilities
Responsible for Process Validation, Annual Product Quality Review and Cleaning Validation
Responsible for Supplier Qualification
Participate in internal audit program & risk assessment systems
Responsible for Aseptic Process Simulation studies
Responsible for Holding time studies
Responsible for Risk Assessment
Responsible For GMP training

QA Senior

ATCO Pharma

Menoufeya

06.2012 - 07.2014

Responsible For Validation, Qualification, Regulatory affairs, Internal audit,Supplier Evaluation, Change Control & Risk Assessment.

Microbiologist

ATCO Pharma

Menoufeya

08.2011 - 05.2012

Full Microbiological analysis for, Raw materials, primary packaging materials & finished goods according to official pharmacopeis & in house specifications
Antibiotic Assay for Raw materials & Finished goods including calculations of potency
Preparation & Evaluation (Growth promotion) of different culture media
Environmental control for classified areas including microbiology laboratory & production area according to ISO 14644 & Relevant USP
Microbiological Water analysis then collect data for trending it
Follow up Calibration and validation of microbiological equipments

Education

Bachelor of Science - Pharmaceutical Sciences

Tanta University, Tanta, Egypt

09.2006 - 09.2011

MBA - General

University of East London, London, UK (Online Degree)

01.2022 - 12.2024

Skills

Strategic planning

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Software

SAP

MS Office

Oracle

Certification

CTD Professional by EDA

Timeline

Operational Excellence Foundations

08-2022

Quality Management Foundations

08-2022

University of East London - MBA, General

01.2022 - 12.2024

Operational Quality Manager - Marcyrl Pharmaceutical Industries

03.2021 - Current

ISO 9001 By AQS

01-2021

ISO 45001 By AQS

01-2021

ISO 17025 By AQS

01-2021

ISO 18001 By AQS

01-2021

CTD Professional by EDA

02-2020

New Products Quality Head - Marcyrl Pharmaceutical Industries

01.2019 - 02.2021

Compliance and Validation Assistant Manager - Julphar Saudi Arabia

04.2018 - 12.2018

Quality Assurance and Validation Manager - Riva Pharma

04.2016 - 03.2018

Quality Assurance Assistant Manager - RIVA pharma

01.2016 - 04.2016

Validation & Qualification Section Head - Rameda

08.2014 - 12.2015

QA Senior - ATCO Pharma

06.2012 - 07.2014

Microbiologist - ATCO Pharma

08.2011 - 05.2012

Tanta University - Bachelor of Science, Pharmaceutical Sciences

09.2006 - 09.2011