Feb 2005Sep 2009
Mar 2010Dec 2010
(Diploma of Biochemistry & Analytical chemistry 2010)
Quality Assurance Specialist (as Documentation officer )
Delta Pharma Limited
-Document control for SOPs & Batch records
-Batch reviewing for different dosage form sterile( ampoule, vial ) & non-sterile(Capsule, Tablet, Oral suspension).
-working to perform and implement "change control" in different department as Quality control, production,ware house and more.
-Deal with"Deviations" that is appear in different fields
-conduct "Internal Audit" in different departments in the factory, write CAPA and follow on it.
-Part from the team that deals with"External Audit" as ISO, and MOH audit.
-open investigations for recall and complains and follow on it
. -Responsible for reporting of KPIs (Key Performance Indicator) .
-Did In-process checking and sampling for Intermediate, Bulk Finished and Finished Product.
Feb 2012Jun 2014
Quality Assurance Inspector in Sterile Area
- Follow up the implementation of cleaning according to the SOP.
- Follow up the implementation of the correct Gowning procedures according to the SOP.
- Check the result of analysis for WFI chemically and microbiologically.
- Check the BMS report that indicates the required Temp., Humidity and deferential pressure.
- Check that all testes of Environmental monitoring are performed.
- Check the result of analysis for pure steam and Nitrogen.
- Checks that the WFI in preparation tank and will used for preparation process are meets the quality required for T.O.C, pH, conductivity and L.A.L test.
- Check the record of the integrity test before and after preparations.
- Check the record for sterilization process for filters, stopper and gowning garment.
- Check the record of CIP and SIP for all tanks involved in preparation process.
- Check that all processes performed at the right prescribed method.
- Recording the manufacturing date, which start at the Preparation step of starting materials according to the batch processing record.
- Sampling the IPC sample after finishing the preparation process and delivering it to Q.C. Lab
- Report the microbiologist to take the bio burden sample
- Filtration process:
- Check filter and review integrity test results
- Check the process
- Filling Process:
- Review the IPC COA for non-validated products and receiving it from Q.C.
- Attached the COA to the batch record and informing the production super visor by the filling decision.
- Follow up the Filling process By Implemented the IPC tests and recorded it in batch record.
- Tunnel step:
- Follow up by check the setting parameter
- Check the process and review the chart.
- Capping ( In Case of Vial):
- Check cap status
- Visual Inspection:
- Follow up visual inspection according to SOP.
Aug 2010Dec 2011
- Oversees the receipt of the reviewed batch record (by Production Manager) from associate administration BR.
- Follows-up the cleaning & setup of the processing line with the Production Technician in accordance with the instructions of the operation and cleaning of machines.
- Starts up of the preparation according to the steps and the environmental conditions listed on the Batch record.
- Follows the startup of filling and packaging operations with production technician and packaging supervisor and maintenance if needed
- Follows-up the reconciliation and delivery of overstocks after distinguish by card (HOLD) until quality approval to deal with it in accordance with the instructions of the rework, while maintaining the percentage of waste of the batches.
- Reports the need for unplanned maintenance of machinery during operation by using the reporting form for failure during operation.
- Issue logbooks for different equipment's in production area and record it and environmental monitoring.
Oct 2012Dec 2012
Good Manufacturing Practice (GMP).
By: Dr/ Wefak Mohamed Abd-Elmoneim (GMP, QA and Technical Training Consultant)
Description basis to deal with pharma product according to GMP.
all activities in all pharma industry. documentation & inspection and production
activities in warehousing.
Internal Auditing Course
Oct 2011Dec 2011
Total Quality Management (TQM)
soft ware - minitab
Able to use minitab in data analysis & APR
prepare registration document & archiving it.