Quality Assurance Department
SPIMACO
Total des années d'expérience :28 years, 3 Mois
(As QA Documentation Team Leader)
The main objectives of (Quality Assurance Documentation Officer ) is to provide assistance to the section head to carry out the tasks required from the section and to ensure and control accessibility of vital information within the company
•Batch Documents collation, then Review and approval
•Prepare Samples for Licensors and Ministry of Health
•Issuance, Monitoring, and Retrieval of the documents e.g. .:
oQuality Control Specification Method QCSM
oStandard Operation Procedure SOP
oChange Control Form CCF
oInstallation Qualification IQ
oOperation qualification OQ
oPerformance Qualification PQ
oIncident reports either GMP, environmental(EMS) or Quality incidents
Deviation system (all types)
•Preparation of Annual Review report (Estimation, Forecast, Target, Achievements)
•Preparation of Quarter report
•Preparation, review and approval of supplier Packaging component wallets and Electronics CD`s
•Validation Files Maintenance (approval, issuance, Distributing, review and follow up)
•Review of Manufacturing process specification
• SOP file Maintenance
•Using. System Application and Products ( SAP system )
•Target and Achievements report
•Cost saving.
• Annual Review for the Products to the higher management
•Communication with licensors regarding their Products Quality
•Risk management.
•GAP analysis comparison study
As Sales and Product Representative.
• Promotion Activities for SPIMACO products.
•Feed-back information providing.
•Handling the customer complains.
• Customers Convenience toward the company Products
As a Finish products, Semi finish products, raw materials & chemicals analyst
The main objective is to analyze the raw materials (Active or non
active) Semi-finished and Finished goods and also to Monitor the stability Samples Study Either by Physical or Chemical Procedure by using analytical or instrument methods
Some Equipment used in Quality control Labs
• WATERS HPLC 712, 717 plus worked on Millennium 3.0 &3.2 Software
• VARIAN 3400 Gas Chromatography
• UNICAM 5500 UV-VIS Spectrophotometer
• TOC Total Organic Carbon Detector
• Parken Elmer 1100B Atomic Absorption
• FTIR Infrared spectrum
• Mettler D25 Auto titrator
• ABBE refract meter for optical rotation determination
• PHILIPS conduct meter for water conductivity
• KARLFISHER method Auto titrator
• UV loss weight Balance