Reseach & Development section head ( Officer )
Saudi Arabian Japanese pharma ( SAJA pharma )
مجموع سنوات الخبرة :14 years, 10 أشهر
F Formulation department :
Supervise the lab activities & ensure cGMP & EHS implementation.
Provide scientific, technical and operational support of drug products development.
Follow up the stock of API & Excipiens in the lab.
Prepare SOPs & ensure technical & quality aspects.
Prepare Master formula & Development report for registration file .
Literature survey including:
Patent status - BCS - In-vivo, In-vitro assessment - API specification -
Excipients specification -packaging suitability.
Pre-Formulation studies including:
API characterization - compressibility testing - Crystalinity - polymorphism -
API & Excipient compatibility testing using DSC, HPLC .
Formulate & develop the formulation process of solid dosage forms of pharmaceutical products.
Identify Ingredient dependent issues within formulation & processes.
Analyze, follow up and summarize the trials results.
Costing of the material quantities and man - machines hours for each trial.
Determine suitable primary & secondary packaging tools for new products.
Production department (Pilot Stage )
Prepare BMR & BPR for pilot Batches scale
Ensure Following up SOPs to fully implement the compliance to cGMP & EHS.
Set up the parameters of the machines in the production to facilitate an easy transfer of the pharmaceutical products from R&D lab.
Set up QbD protocol & follow up its implementation.
Provide direction, correction & motivate the operators to achieve the target quality at time schedule.
Manage the scientific, technical and operational trouble shootings occur.
Calculate Overall Equipment Effectiveness (OEE) involving calculate availability, performance & quality factors .
Analytical research department :
1- Analysis of R&D Formulation & R&D Stability samples of different forms using different types of HPLC (Alliance-Breeze-shimadzu), ACQUITY H Class UPLC Waters, UV spectroscopy apparatuses & Titration Methods.
2- Making Biowaiver Studies according to FDA Guidance.
3- Establish & develop new analytical methods for analysis of different forms of pharmaceutical preparations.
4- Making Validation of the Analytical Methods .
5- Establish methods for detecting cleaning residues & making cleaning validation.
6- Management of Trouble shooting in different apparatuses with time planning schedule .
7- Stability of R&D Samples:
A) - Analysis of stability samples including their related substances.
B) - Making stability indicating Methods & Making Forced degradation Methods For different forms of pharmaceutical products.
C) - Making stability studies of different forms of pharmaceutical Products In various conditions of Temperature & Humidity.
8- Writing General, instrumental, chemical SOPs with full implementation & ensuring compliance to GLP.
1- Analysis of R&D formulation samples of different forms
Using different types of HPLC (Alliance-Breeze-shimadzu), ACQUITY Uplc Waters, GC, UV spectroscopy apparatuses & Titration Methods.
2- Formulate & Develop the formulation process of different forms of pharmaceutical products .
3- Identify Ingredient dependent issues within formulation & processes .
4- Provide scientific, technical and operational support of drug product development.
5- Stability & Methodology :
A) - Analysis of stability samples including their related substances .
B) - Making stability indicating Methods & Making Forced degradation Methods For different forms of pharmaceutical products.
C) - Making stability studies of different forms of pharmaceutical Products In various conditions of Temperature & Humidity.
6- Making Validation of the Analytical Methods .
7- Establish & develop new analytical methods for analysis of different forms Of pharmaceutical preparations.
8- Making Biowaiver Studies according to FDA Guidance .
9- Management of of Trouble shooting in different apparatuses with time planning schedule.
10- Writing General, instrumental, chemical SOPs with full implementation & ensuring compliance to GLP.
11- preparing different types of testing & volumetric solutions and adjust the requires factors according to USP.
1- Participate in the start up of the lab .
2- Analysis of QC Finished & Raw material of different forms
Using different types of HPLC (Alliance-Breeze-shimadzu), ACQUITY Uplc Waters, GC, UV spectroscopy apparatuses & Titration Methods.
3- Formulate & Develop the formulation process of different forms of pharmaceutical products .
4- Identify Ingredient dependent issues within formulation & processes .
5- Provide scientific, technical and operational support of drug product development.
6- Stability & Methodology :
A) - Analysis of stability samples including their related substances .
B) - Making stability indicating Methods & Making Forced degradation Methods For different forms of pharmaceutical products.
C) - Making stability studies of different forms of pharmaceutical Products In various conditions of Temperature & Humidity.
7- Making Validation of the Analytical Methods .
8- Establish & develop new analytical methods for analysis of different forms Of pharmaceutical preparations.
9- Making Biowaiver Studies according to FDA Guidance .
10- Management of of Trouble shooting in different apparatuses with time planning schedule.
11- Writing General, instrumental, chemical SOPs with full implementation & ensuring compliance to GLP.
12- preparing different types of testing & volumetric solutions and adjust the requires factors according to USP.
1- Analysis of R&D Formulation & Stability samples of different forms
Using different types of HPLC (Alliance-Breeze-shimadzu), ACQUITY Uplc Waters, GC, UV spectroscopy apparatuses & Titration Methods.
2- Stability & Methodology :
A) - Analysis of stability samples including their related substances .
B) - Making stability indicating Methods & Making Forced degradation Methods For different forms of pharmaceutical products.
C) - Making stability studies of different forms of pharmaceutical Products In various conditions of Temperature & Humidity.
3- Making Validation of the Analytical Methods .
4- Establish & develop new analytical methods for analysis of different forms Of pharmaceutical preparations.
5- Making Biowaiver Studies according to FDA Guidance .
6- Management of of Trouble shooting in different apparatuses with time planning schedule.
7- Writing General, instrumental, chemical SOPs with full implementation & ensuring compliance to GLP.
8- preparing different types of testing & volumetric solutions and adjust the requires factors according to USP.
Pharmacy Bachelor from Zagazig University with excellent grade. (86.11%) with honor degree (May 2009