Product Development Manager
Danone
مجموع سنوات الخبرة :11 years, 8 أشهر
Management of Calibration routines in the Analytical laboratories.
Analytical Method Transfer of Products introduced into or out GlaxoSmithKline El-Salam Site
Analytical Method Validation of Newly Developed Method & its Periodic Review.
Analytical Method Development for New Products introduced to the Site.
In-vitro bioequivalence testing according to Periodic and regulatory Routines.
Managing Chemical Stores.
Cleaning Validation
Issuing Technical Documentations on various Analytical techniques, Equipment Calibration and operation routines.
Analysis of GlaxoSmithKline's Finished Products of Different Dosage forms (Capsules, Syrups, Tablets, Ampoules, Suspensions and Semisolids) according to Weekly Plan.
Analysis of 3rd Party Products "Novartis & Sandoz"
Analysis of Stability Samples along with the Release Samples.
Analysis of Some Purchased Raw Materials and APIs According to GlaxoSmithKline’s Specifications
Working on UPLC & HPLC (Waters & Agilent), GC (Agilent), Atomic and UV Spectroscopy instruments (Agilent).
Performing Method, Process & Cleaning Validation
Responsible of Chemical Reagents Inventory and its Management
Member of The Process Validation Project “Validation of all GlaxoSmithKline’s Current Products on all Production’s machinery”
Analysis of Eva Pharma's Finished Products of Different Dosage forms (Capsules, Syrups, Tablets, Ampoules, Powders & Semisolids) according to Daily Plan.
Analysis of 3rd Party Products "Pfizer"
Scale up Analysis of R&D's New Products.
Analysis of Some Purchased Raw Materials and APIs.
Working on UPLC & HPLC (Agilant & Merck LaChrome), GC (Agilant & Varian), Atomic and UV Spectroscopy instruments.
Troubleshooting and resolving operations issues.
Internal Calibration of instruments according to work instructions to ensure compliance to standards. (Responsible of The Daily Calibration of the pH meter)
Preformed Method Validation for both the assay and Dissolution methods of finished Products to ensure products’ compliance to standards. (Deslorat Tab., Prazolam Tab.)
Preformed Process Validation (CTD) of Finished Products (Thiotacid 600mg tab.)
Introduced the Labelling system to the Whole quality Department throughout all the Labs