Highlights:I have an cGMP experience in 3 years as a quality personnel. I have a hardworking and disciplined personality which enables me to exceed my goals. I proved myself in quality control and quality assurance requirements, time management and trend tracking. I am good at writing SOPs and resolving troubleshootings of quality test results with my strong researcher background, and i can take actions with CAPA to resolve OOS circumstances.

Skills:GMP, Quality Management System, CAPA, Internal / External Audits, SAP, QMex, SOP

Goal:I have a passion for quality management system, so i want to walk each stone of the quality and one day i want to reach the last one. I would like to eventually become a lead auditor in the authorities with the experience I have gained.

Certification:• GXP Training Programme- Academia Yasam Bilimleri / May- July 2022 ? Environmental Stabile Area ? Test Method Validation ? Microbiological Test Method Validation ? GMP for ATMPs -Deviation Management and Corrective and Preventive actions (CAPA) ? Sterile Production and Good Distribution Practice (GDP) ? Internal audit, supplier management, annual quality assurance assessment (AQAA) ? Validation, Qualification -Risk management -Process validation, risk assessment • Navios Flow Cytometry User Training - Beckman Coulter / August 2023 • Apex Z3 Particle Counter User Training- Lighthouse/ July 2023 • TC20 Automatic Cell Counter System- BIORAD / November 2022 • Maxisafe User Training- Thermo Scientific/ June 2020 • LMS Express 8 Cleanroom Monitoring System Software - Lighthouse/September 2022 • Kinetic Turbidimetric Bacterial Endotoxin Test and ACC Cape Cod Pyros Kinetic Flex System- Ant Medical /October 2022

Honor:Biotechnology Master of Degree - Graduated Magna Cum Laude 4,00 GPA, Awarded with Honor Certificate

Quality Assurance Specialist 04/2024 - current
Biofarma, Istanbul, United States
Industry: Pharmaceutical Company
I am currently working in Biofarma, i am responsible for whole internal and external audit processes, in case of findings, i am taking ations with CAPA, at the same time i am writing SOPs on QMex and i have some authorizations on SAP system.
Managing an electronic document system for the final product management system (SAP) which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state ? Writing and revise document control procedures including participating in the development and roll-out of document control tools ? Following policies, SOPs, and work instructions to support the document approval process, assign effective dates, archiving documents and document change requests ? Generating document management system (QMex) reports for Quality Council metric reporting ? Supporting internal, external audits and regulatory inspections, assisting with document retrieval /organization support--
Quality Personnel 08/2022 - 03/2024
YUCTEC, Istanbul, United States
Industry: Pharmaceutical/ Biotechnology
In this process, we established our quality management system according to USP, EP, ICH and TITCK GMP guidelines. I played an active role in the writing of SOPs. I also carried out quality control validation studies of the products with reference to the guidelines and observed the process as IPC by entering the production part.
Performing QC tests (Flow Cytometry, PCR, BET, Membran Filtration, Gram staining, cell counting) for raw materials and products (MSC, NK, T, CAR-T, Exosome) ? Microbiological testing ? Designing and performing test method validation protocols and reporting ? Environmental monitoring with routinely sampling ? Documenting of standard operation procedures (SOP) ? Taking action in case of OOS, OOT and CAPA ? Auditing of storage control, Managing stability validation period ? In Process Control (IPC) ? To be stay aware of current ICH, USP, EP quality standards and best practices--
Production Analyst 07/2021 - 08/2022
YUCTEC, Istanbul, United States
Industry: Pharmaceutical/ Biotechnology
YUCTEC was a start-up company and it has some challenges. For this reason, I developed myself than any pharmaceutical company about GMP requirements of a facility. In this period, besides being a producer, I experienced how to setup a GMP laboratory. I experienced what requirements are necessary to be a GMP lab., design of the clean rooms, pressure levels of clean rooms, communicate with companies and writing technical specifications.
Cell culture of primary tissue and intermediate products ? Documentation of standard operation procedures (SOP), instructions, process validation protocols and their reports ? Final product productions (MSC, CAR-T, NK, T cells, Exosome) ? Aseptic Process Simulation (Media fill)--
Research Assistant 07/2019 - 08/2022
Yeditepe University, Istanbul, United States
Industry: Research
I researched "How VitD3 affects DC-T cell interaction" in Immunogenetic Laboratory and in this period i was an instructor of Analytical Chemistry Lab.
? Preparing written technical documentation to detail research findings and interpretations ? Collecting data protocols to increase precision and accuracy of test results Studied Projects: ? Investigating VitD3 on DC-T cell interaction and their responses on immune system ? Investigating boron derivative material treatments on immune cells--

Yeditepe University 09/2014 - 06/2019
Istanbul, , United States
Degree: Bachelor's Degree
Major:Genetics and Bioengineering
I succesfully graduated with a thesis of "Prophylactic Effect Of MSC Derived Exosomes onto Acrylamide Treated SH-SY5Y Cell Line".

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