Burak Y.

Entrepreneurial expert with 8 years of biotech / pharma industry experience. Expert in strategic planning and organization. Goal-oriented, with the ability to achieve long-term goals through daily organization. Committing to excellent in-house customer service and team communication. Sophisticated and elegant in managing high-volume workloads in rapidly changing environments. Good at prioritizing tasks, maintaining organization and optimizing workflow. Expert with more than 7 years of successful experience in the fields of Quality Assurance and Engineering. It has been consistently recognized in the Biotech / Pharma industry for its performance excellence and contribution to success. As an enthusiastic Expert, is willing to contribute to team success with hard work, attention to detail and excellent organizational skills. Educated about the processes has carried out until today. Motivated to new challenges, grow and excel in the consultant. Burak planned, carried out and reported calibration, qualification and validation activities of Laboratory, Utilities, Pharmaceutical equipment and devices together with team in accordance with ICH, FDA and GMP regulations. Burak also managed maintenance and breakdown processes of Lab devices together with team. By installing 5S system, it reduced losses in its department and increased order and work efficiency. With trainings Burak gave to team on this issue, increased awareness and made efforts to make this lifestyle. As part of energy efficiency team, carried out ISO 50001 Energy Efficiency Management System activities and brought new system to company and provided financial returns with studies on this subject. Burak managed investment budget and operating budget of department. Burak performed audit activities within company as cGMP internal auditor. As technical department member, Burak guided new maintenance and calibration software with team and ensured that system was put into use properly and validly. Contributed to digitization of company's manually operated processes. With implementation of this software, business processes have become efficient and at same time, financial returns have been provided to company. Burak planned, implemented and reported of Lab & Pharma Equipment and Devices periodically Calibration, Qualification and Validation activities according cGMP regulation. Burak planned, implemented and reported activities of internal audits within scope of cGMP & PICs regulation. Burak planned, implemented and reported of domestic and international supplier company (Calibration, Raw Material, Packaging Material & Environmental suppliers) audits. Burak planned, implemented and reported of computerized systems validation activities according to Gamp 5. Burak performed Clean Room Setup (HVAC, Rooms and Utilities) and Verification activities in accordance with ISO 14644. Verified data was defined into BMS-Scada (Building Management System) system and protected from modification. Burak monitored KPI parameters determined by Head of QA quarterly and ensured that necessary actions were taken to increase percentage of reaching targets. Burak as team leader, took actions in order to establishment ISO 14001 Environmental Management System and OHSAS 18001/ 45001 Occupational Health and Safety Management System, increase awareness and ensure its continuity. Burak as team leader, took actions in order to establishment ISO 13485 Medical Devices Management System, increase awareness and ensure its continuity. Burak as team leader, to took action, to increase awareness and to ensure its continuity in order to integrate ISO 27001 Information Security System and BS 10012 GDPR Management System. Burak has carried out activities to ensure data integrity, increase awareness and ensure continuity in laboratory and pharmaceutical equipment and devices. Burak, in processes carried out, effective risk analysis and assessment process was carried out with risk-based approach. (FMEA, ISO 14971, SWOT, ISO 31010) Validated operation of PM (Preventive Maintenance) module of SAP / ERP software used in processes. Burak as responsible of PM (Preventive Maintenance) module ensured that PM module of SAP / ERP software used in processes works in validated manner. Burak works about AI Training and content developing at Outliers AI and also work to create the new articles, fixing plagiarism and rewrite of articles.