Müberra Şen Kayan Email & Phone Number

1. To perform the qualifications of the materials used in production and other material/ service suppliers that affect the quality2. To evaluate annual quality performances, update the classifications (pass-fail grading system), prepare the supplier performance cards3. To perform the non-disclosure aggrement with suppliers4. To plan and coordinate overseas supplier audits, follow up the actions and CAPA reports5. To follow the quality nonconformity reports published by the authorities about the suppliers and to inform the relevant departments about the actions to be taken.6. To prepare supplier declarations for relevant authorities and customers7. To participate and assist in authority and customer audits at production sites8. To record and evaluate the change notification from suppliers and initiate change control when necessary. 9. To apply risk based approach for raw material, packaging material and quality related material/serivce according to the procedures10. To perform the excipient risk assesments with R&D department

- To implement analytical method validation, verification and analytical method transfers (including international transfers). -To supervise associated testing of stability studies conducted as per plan, preparing protocols and reports.-To prepare necessary documents in accordance with regulatory and international market requirements-To implement quality systems for Quality Control with FDA requirements.-To conduct laboratory investigations to produce reports in response to OOS.-To design and maintain training programs for QC staff.-To provide SOPs,protocols and reports.-To provide input, guidance and coaching to the team and constantly follow up the team performance,-To establish key performance indicator (KPI) for quality control department -To manage and follow the internal and external quality audits and to submit the results to the management

Ankara

Method development and validation studies using HPLC, LC-MSD, LC-MS/MS and UPLC-MS/MS, laboratory studies proper with GLP and preparing the reports.

Chemistry (Msc)

Chemistry