MOHAMED SHEHATA

• Leading quality department in the setup, preparation and operation launch of the new GEPD plasma donation center in Port said city, participating as quality manager in the successful passing of all required audits and inspections in order to hold the regulatory operation license for the plasma donation center.
• Performed root cause analysis to identify and resolve quality issues and defects.
• Recorded, analyzed, and distributed statistical information.
• Implemented corrective action plans based on audit findings, resulting in measurable improvements over time.
• Participated as quality lead in diverse audit and inspection processes i.e (EMA, EDA, EDA-GMP, IQPP, Grifols CQA)
• Responsible for the personnel functions of the quality assurance specialists
• Collaborating with other operation departments to ensure the effective implementation and compliance to the Egyptian regulations and the GEPD standard operation procedures for providing the optimum level of donor safety, product quality and GxP Process compliance and efficiency.
• Quality review for documents of donors, equipment certificates, calibration certificates, validation processes, etc.
• Certified QA trainer, participated in training the subsequent waves of newly hired (quality specialists/ quality managers) at GEPD Corporate, on the quality system with all related SOPs , quality standards , and day to day work basis.
• Deviation management and review with professional documentation, submission, and archiving
• CAPAs management and follow up, effective monitoring for the implemented corrective and preventive actions across all production areas
• Conduction of internal audits, responding to external audits and assessments for facility and all activities are being performed within donation center

Participant member in founding the quality system in all GEPD plasma donation centers to ensure the efficient implementation of all quality aspects, standards and policies

• Participated in creating and developing the first effective set of standard operation procedures (SOPs) for GEPD donor centers and launching the first donation center (6th of October DC)
• Participated as quality lead in diverse audit and inspection processes i.e (EMA, EDA-GMP, IQPP, Grifols CQA).
• Responsible QA lead to perform QA inspection and the central QA release of the donation supplies and soft-goods in central warehouse for all GEPD donor centers.
• Delegated (acting as CQM) to support our new GEPD Donor Center in Suez city during the operation launch and opening, passing all requited audit and inspections process.
• Certified QA trainer, participated in training the subsequent waves of newly hired (quality specialists/ quality managers) on the quality system with all related SOPs, and day to day work basis
• Deviation management and review with professional documentation, submission and archiving
• CAPAs management and follow up, effective monitoring for the implemented corrective and preventive actions across all production areas
• Conduction of internal audits and assessments for facility and all activities are being performed within donation center
• Quality review for documents of donors, equipment certificates, calibration certificates, validation processes, etc.