Experience

Future Research Center

• Egypt
• Research Services
• 1 - 100 Employee

• Quality Assurance Specialist

  • May 2023 - Present

  ◇ Develop, Implement and monitor the quality management system according to the international and local requirements as ICH-GCP GLP WHO, ISO9001-2015& 17025-2017. ◇ Revised and check the protocols, consent form and case report form before the initiation of the study. ◇ Monitor and conduct regular audits according to the international standards to all the departments and the related processes which include "the clinical site, in-vitro, in-vivo laboratories, screening process, biological sample store, chemical stores, pharmacy unit and archive unit" to ensure that all the activates was performed as the stated procedures and related SOPs. ◇ Determining, negotiating and agreeing with the responsible staff on quality procedures standards and specifications. ◇ Assessing customer requirements and ensuring that these are met. ◇ Working with operating staff to establish procedures, standards and SOPs. ◇ Determining training needs, conduct training to the staff, implement all the training cycle evaluate the training programs. ◇ Acting as a catalyst for change and improvement in the quality performance. ◇ Directing objectives for the continuous improvement in the quality management system. ◇ Identify quality problems and recommend solutions. Show less



Pharmasolutions CRO

• Egypt
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Clinical Investigator

  • Mar 2022 - Apr 2023

  ◇ Manage recruiting, selection and screening of clinical study subjects.◇ Responsible for communications with contracted medical Laboratories, part timer medical staff.◇ Responsible for preparation of volunteer list for regulatory authorities for approval and study appointment determination.◇ Supervise subjects and handling Check in-out, admission activities and randomization.◇ Receive drugs doses prepared for study drug administration and revise it with randomization scheme.◇ Supervising and responsible for plasma samples withdrawal, separation, packaging and final destruction.◇ Responsible for adverse event preparation and monitoring.◇ Participate in preparation of clinical study protocol and implementation of GCP.◇ Confirm that all clinical studies tasks are done according to the stated study protocol and relate SOPs.◇ Responsible for informed consent form obtaining & instructions for the study, demographic data and screening questionnaire.◇ Responsible for conducting medically related procedures, A=urine sampling, B=Narcotic drug test, C=alcohol urine test, D=vital signs recording, E=ECG performance, F=pregnancy test, G=PK blood sample collection, H=laboratory blood sample collection.◇ Responsible for admission questionnaire.◇ Responsible for reviewing prepared doses and drug administration.◇ handling investigational product. receiving, storage, inventory, dose preparation and labelling.◇ Dealing with randomization scheme, distribute to clinical site, accountability and final destruction.◇ Responsible for reviewing case report form.◇ Responsible for handling plasma samples. Show less

• Clinical Investigator

  • Dec 2021 - Mar 2022

  ◇ Bioequivalence, bioavailability and biostability analyst.



Elmeliegy & Metra laboratories

• Lab Specialist (Chemist)

  • Jun 2019 - Jun 2020

  ◇ Trained in all fields of lab work and also to withdraw and take samples perfectly and responsible for the laboratory and tests by receiving, handling and doing tests by semi-automated and manual techniques under the standards of good practices. ◇ Trained in all fields of lab work and also to withdraw and take samples perfectly and responsible for the laboratory and tests by receiving, handling and doing tests by semi-automated and manual techniques under the standards of good practices.



Damanhour medical national hospital

• Lab Specialist (Microbiologist)

  • Jun 2018 - Nov 2018

  ◇ Trained in all fields of lab work by using full automated devices, semi-automated, manual and also to withdraw and take samples perfectly. ◇ Trained in all fields of lab work by using full automated devices, semi-automated, manual and also to withdraw and take samples perfectly.