Semra Aybek Email & Phone Number

The Hague, Zh, Nl

Leiden, South Holland, Netherlands

Netherlands

Responsibilities:*Managed the packaging, invoicing, and shipment processes for medication orders received from international companies.*Utilized computer systems to efficiently complete packaging procedures.*Oversaw the placement and inspection of incoming products in their designated warehouse locations.*Maintained the organization and cleanliness of the warehouse on a daily basis.Upon moving to the Netherlands, I took on this role as an opportunity to learn new skills and integrate into Dutch society. Although it was outside my primary field, I embraced the chance to develop valuable relationships with colleagues from diverse backgrounds and enhanced my organizational and technical abilities. In May 2023, I decided to leave this position to fully focus on pursuing my professional career in Quality Management, where my expertise and passion lie.

Istanbul, Turkey

*Documented all processes within RVM Systems in accordance with ISO management systems.*Ensured compliance with current regulations regarding deposit return systems.*Gained experience in quality within a production environment in the RVM System.*Provided support to the Project and Operations teams in all aspects of safety, occupational health, and environmental issues.*Conducted sustainability studies on deposit return systems while supporting the RVM system.*Monitored national fairs related to deposit return systems and completed necessary preliminary preparations.*Assisted the RVM Systems Project and Operations team in security, occupational health, safety, and environmental matters following the completion of a recent course.*Participated in internal GMP inspections and customer inspections.*Managed the scheduling and recording of hotel and flight reservations, visa applications, meeting schedules, appointments, and business meetings for the CEO.

Istanbul, Turkey

*Worked closely with the quality team to renew the ISO 9001:2015 and ISO 13485 management systems for medical devices.*Supported internal and external audits with the quality team.*Received occupational health and safety training and, in collaboration with the occupational health and safety specialist, identified potential risk analyses. Conducted earthquake drills, determined emergency exits, designated the first aid and rescue team, and ensured they received necessary training.*Ensured strict compliance with GMP procedures within QC. Checked compliance with GMP procedures (for example logbooks, order and tidiness, documentation, etc.).*Supported QC management with regards to all developments in the field of quality, GMP, and legal guidelines and played an important role in further and broader integration of quality in the company.*Ensured sales teams adhered to the latest medical device regulations and guidelines, and provided necessary meetings.*Maintained agendas and calendars, organized and planned internal and external meetings, and completed necessary preparations for conferences.*Managed the scheduling and recording of hotel and flight reservations, appointments, and business meetings for the CEO. Collected and analyzed information to prepare reports from meetings.

Istanbul, Turkey

*Performed spot audits and formulated CAPA in collaboration with the QA department.*Managed the ISO 9001:2015 certified quality management system, including internal and external audits with detailed reporting, follow-up activities, and complaint handling.*Ensured correct administration (Trackwise) with regards to QC-related Changes/Deviations, training courses, and CAPAs.*Solved CAPA problems using the 5 Whys method.*Provided support for Field Safety Corrective Actions and recorded process complaints in the system.*Improved the quality management system by keeping quality processes and documentation updated.*Supported EH&S standards by determining regulatory requirements.*Conducted risk assessments related to EH&S standards.*Ensured sales teams adhered to the latest medical device regulations and guidelines, and provided necessary meetings.*Supported the continuous development of internal policies and procedures.*Informed all field employees about quality system documents and collaborated on ongoing tasks.*Checked all procedures of medical devices transitioning from MDD to MDR.*Ensured compliance with regulations regarding CE marking and product integrity.*Followed post-market surveillance obligations.*Possessed knowledge and practical application of Quality Assurance principles, Good Manufacturing *Practices (GMP), and Good Distribution Practices (GDP).*Experienced with Standard Operating Procedures (SOPs) and creating job descriptions.*Participated in special interdisciplinary task groups where QC input is desired.

Istanbul, Turkey

Istanbul, Türkiye

*Supporting the establishment, development, implementation, and analysis of quality management systems and making the process operational.*Participating in internal and external company audits based on ISO 140001 and ISO 9001 standards, helping to make observations and create reports.*Having knowledge about lean 6 sigma and supporting the relevant project.*Prepare a project at the end of the internship period and present this project to senior management.

Bursa, Turkey