Moath Hussein Email & Phone Number

Wilayat Salalah, Dhofar, Oman

-Responsible for the preparation of all URS for all solid and sterile lines (vials, ampoules &lyophilized) (Tablets and Capsules) from manufacturing to packaging.-Part of the PMO responsible for the development and verification of the conceptual &detailed designs of Philex’s sterile area, OSD area and quality labs.-PM for Philex QC project (chemical and micro) from sourcing till full operation.-Preparation for Philex’s Solid plant for the GMP license.-In charge of the… Show more -Responsible for the preparation of all URS for all solid and sterile lines (vials, ampoules &lyophilized) (Tablets and Capsules) from manufacturing to packaging.-Part of the PMO responsible for the development and verification of the conceptual &detailed designs of Philex’s sterile area, OSD area and quality labs.-PM for Philex QC project (chemical and micro) from sourcing till full operation.-Preparation for Philex’s Solid plant for the GMP license.-In charge of the project QMS establishment ahead and during GMP license preparation.-Acting Quality Unit Manager leading the preparation and arrangement phase for technologytransfer for QC (chemical and micro), QA and Validation.-Lead the TT project in Philex from RM/ PM sourcing till GCC CTD file variation submission.-Continuous development of the production & quality teams through continuous improvement andmember improvement along with succession plans.-Establishment, sourcing and procurement of all production requirements of furniture, ancillaries,consumables and procedures in place.-Leading the plant SAP core team to lay down the main purchasing requirements as well as BOMs uploading to ERP system.-Multiple cost saving and process improvement projects (Last quality project saving 0.5 M USD),-In charge of building the whole production and quality team in Philex pharma through efficientand scientific sourcing and headhunting talented prospects. Show less

Dammam-Ksa

-Responsible for scale-up, technology transfer and technical process optimization in R&D Pilot Plant and Production.-Sterile products manufacturing, ampoule and vial filling as well as freeze drying operation onboth pilot and production scales.-Liquids, Semi-Solids and Oral Suspension products manufacturing, transfer to production and scale-up.-Preparation of the main pilot area SOPs (Cleaning and sanitization, Process Validation, Filterscleaning/ sterilization and integrity… Show more -Responsible for scale-up, technology transfer and technical process optimization in R&D Pilot Plant and Production.-Sterile products manufacturing, ampoule and vial filling as well as freeze drying operation onboth pilot and production scales.-Liquids, Semi-Solids and Oral Suspension products manufacturing, transfer to production and scale-up.-Preparation of the main pilot area SOPs (Cleaning and sanitization, Process Validation, Filterscleaning/ sterilization and integrity testing, Handling of material flow procedure) in Pilot plant,Entry and exit procedure for pilot sterile area, disinfectant preparation and filtration, cleaning andhandling of glassware/ pp bottles and glassware…etc.).-Product investigation reports, RCA/ CAPA, GAP analysis, Risk assessment and freeze dryingcycle impact assessment.-Over 60 sterile vial/ ampoule/ lyophilized products and Non-sterile liquids and semi-solids (morethan 350 batches) transfer from lab to pilot scale and production scale.-Personnel development and improvement as per cascaded KPIs. Show less

Dammam-Ksa

-Sterile products manufacturing, ampoule and vial filling as well as freeze drying operation all onboth small, pilot and production scales.-Handling pilot area activities for manufacturing, autoclaving cycles loads, containers washing,depyrogenation, filling and capping.-Full operation, Troubleshooting of the Pure Steam Generator, WFI Multicolumn Distillationsystem, Autoclave and Dry Heat Sterilizer.-Multiple FAT and SAT for Sterile pilot and production… Show more -Sterile products manufacturing, ampoule and vial filling as well as freeze drying operation all onboth small, pilot and production scales.-Handling pilot area activities for manufacturing, autoclaving cycles loads, containers washing,depyrogenation, filling and capping.-Full operation, Troubleshooting of the Pure Steam Generator, WFI Multicolumn Distillationsystem, Autoclave and Dry Heat Sterilizer.-Multiple FAT and SAT for Sterile pilot and production machineries.-Full hardware and software operation on freeze dryers.-Filter validation studies and requirements.-Filtration for solutions and integrity testing.-Freeze dried products troubleshooting, cycle development and technology transfer requirements.-Registration and eCTD requirements support as per GCC requirements.-Preparation of Process Operating Instructions (POIs), Process Validation Protocols (PVPs) and Process Validation Reports (PVRs).-Follow up for all pilot products stability studies and stability protocols implementation.-Adaptation and implementation of clean room concepts as per cGMP. Show less

Amman, Amman, Jordan

- Injectable Formulation and Development (Solution and Lyophilized).Scale up and Technology Transfer.- Lyophilization cycle development, technology transfer and troubleshooting.- Compatibility and in-use studies preparation and implementation.- Stability protocols preparation and stability data interpretation.- Preparation of development reports and batch records.

Routine Analysis (Stability) and Analytical Method Validation.