Quality Assurance Sr.Officer
Delta Pharma
مجموع سنوات الخبرة :12 years, 4 أشهر
Responsible for:
Document control for SOPs & Batch records through Issuing, modifying and canceling the standard operating procedures (SOP) and follow it up till effective beside annual audit &receiving Master formula, preparing and issuing Batch Record after approval it from all senior management and distributed it to all management according to the distribution list.
1/2012 until Now: Working in Quality Assurance Department in Delta-Pharma Company. (10th of Ramadan city)
Regulatory Affairs Preparing finished products papers for Ministry of Health sampling and sampling raw material & finish product required. The ability to view the batches to be sampled by the Ministry of Health after reviewing of all the attachments that are displayed on the MOH Inspector.
Batch Record Review (Sterile & Non-sterile batches) according to checklist & Follow up quarantine area & daily release and prepare data to be analysis of annual product review( APR).
Able to prepare & update Site Master File (SMF).
Investigate and respond to customer complaints & Ensures product complaints are logged, investigated, and resolved according to established deadlines, company and GMP requirements.
And archive it.
Working to perform and implement "change control" in different department as Quality control, production, ware house and more.
Responsible for reporting of KPIs (Key Performance Indicator).
Ensure that all Qualifications & Validations activities in the plant are performed & executed as pre-planned & report that to QA Manager.
Manage deviation report follow up& archive it .
Internal auditor with reference (WHO GMP& ISO 9001& ISO 14001 and OHSAS 18001).
Part from the team that deals with “External Audit" as ISO, and MOH audit.
Main Achievements.
Site master file, validation master plan, Quality Manual and APR.
Responsible for:
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 micro-biologically.
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.
Preparation:
-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
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 .