أحمد عوض, Quality Assurance Sr.Officer

أحمد عوض

Quality Assurance Sr.Officer

Delta Pharma

البلد
مصر
التعليم
دبلوم عالي, Bio chemistry & Analytical chemistry
الخبرات
12 years, 4 أشهر

مشاركة سيرتي الذاتية

حظر المستخدم


الخبرة العملية

مجموع سنوات الخبرة :12 years, 4 أشهر

Quality Assurance Sr.Officer في Delta Pharma
  • مصر - القاهرة
  • أشغل هذه الوظيفة منذ فبراير 2012

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.

Quality Assurance Specialist ( ipc) في Delta PHarma
  • مصر - القاهرة
  • فبراير 2012 إلى يونيو 2014

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 .

الخلفية التعليمية

دبلوم عالي, Bio chemistry & Analytical chemistry
  • في Menoufia University
  • سبتمبر 2010
بكالوريوس, Bachelor of science ( chemist)
  • في cairo university
  • يوليو 2009

Specialties & Skills

finalized task
presentation
communication

اللغات

الانجليزية
متمرّس
العربية
اللغة الأم

التدريب و الشهادات

Total quality management (TQM). (الشهادة)
تاريخ الدورة:
April 2012
GMP (تدريب)
معهد التدريب:
Dr/ Wefak Mohamed Abd-Elmoneim (GMP,QA and Technical Training Consultant)
تاريخ الدورة:
June 2012
المدة:
18 ساعة
Auditor /Lead Auditor Training Course (Quality Management System) ISO 9001:2015. (تدريب)
معهد التدريب:
IRCA
المدة:
15 ساعة
Internal Auditing Course (ISO 9001:2008) (تدريب)
معهد التدريب:
Engineering and Quality Experts (E.Q.E)
تاريخ الدورة:
April 2012
المدة:
10 ساعات