Experience

Heliks AR-GE ve Biyoteknoloji A.Ş.
• Quality Management Director

  • Mar 2023 - Present


Yeditepe Üniversitesi

• Manufacturing Manager

  • Feb 2022 - Mar 2023

  *In accordance with the EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guide, I am involved in the clean room setup and the establishment of production areas. *In addition to the documentation of all production processes, I also support the sterilization, automation and quality control unit. *Establishment of production areas for cellular products in the laboratory that is still in the installation phase (installation of two BSL-2 class rooms in addition to Class B areas), *Determining the product groups to be prepared as the final product for the patient, *Writing all relevant documents of these product groups (procedure, instruction, form, etc.), *Investigation of suitable materials associated with related products, *I prepared the validation master plan and the validation processes (according to ICH Q2) of all units, *Finally, managing the organization of the production team. *Our laboratory is still in the installation phase and there is no active product release. Active product release will be made after the local health ministry inspection is done and approved Show less



A1 Life Sciences

• Quality Management Representative

  • Jan 2021 - Jan 2022

  To carry out quality management according to ISO 13485 Quality Management System. Controlling in vitro products and preparing technical files according to 98/79/EC in vitro medical device regulation. Ensuring that the processes required for the Quality Management System are documented, To report to senior management about the effectiveness of the Quality Management System and any need for improvement, Ensuring increased awareness of applicable legal requirements and quality management system requirements throughout the organization, Following up, updating and transferring external documents to relevant units, To announce the quality policy to the employees and to ensure the development of quality awareness among the employees, Determining, periodically reviewing and evaluating the quality targets together with the management, To prepare the Quality Manual and to control its up-to-dateness, To act as the reporter of the Management Review meeting and to ensure the implementation of the decisions taken. Show less



Liv Hospital Group

• Türkiye
• Hospitals and Health Care
• 700 & Above Employee

• Manufacturing Specialist

  • Jan 2018 - Jan 2021

  Under Good Manufacturing Practices (EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guideline); --> Isolation and proliferation of mesenchymal stem cells from the umbilical cord by explant culture method. Preparation as final product for allogeneic use. --> Isolation and proliferation of adipose derived mesenchymal stem cells from the liposuction product by enzymatic method. Preparation as final product for autologous use. --> Isolation and proliferation of fibroblasts by enzymatic method from tissue taken from the patient by punch biopsy. Preparation as final product for autologous use. -->Isolation and proliferation of chondrocytes by enzymatic method from tissue taken from the cartilage. Preparation as final product for autologous use. -->To validate the quality control tests (gene expression, endotoxin, telomer length) of the produced cells. -->Tasks I have taken outside the GMP laboratory; *To review and revise the procedures and instructions and to provide documentation. Research new procedures that can be added to the processes. *Keeping a record of device calibrations and sending devices for calibration when the day comes. *Creating a training plan (e.g. proper dressing for GMP, qualification of personnel for using of devices) ensuring that the personnel receive the necessary training and documenting these plans. *To follow and document the annual health screenings of the personnel. Show less