Experience

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  Bilim İlaç

  • Istanbul, Turkey

  • Senior Regulatory Affairs Specialist

    • Aug 2020 - Feb 2021
    • Istanbul, Turkey
• 

  MS PHARMA

  • Istanbul, Turkey

  • Regulatpry affairs senior

    • Jan 2020 - Mar 2020
    • Istanbul, Turkey

    Prepare the registration files for export countries in CTD format Respond to questions about the registration processApply for variation

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  Nobel Ilac A.S

  • ISTANBUL/TURKEY

  • Regulatory Affairs Specialist

    • Dec 2006 - Feb 2014
    • ISTANBUL/TURKEY

    <Pharmaceutical company which is API (Active Product Ingredient) and finished product manufacturer. Nobel performs its sales, marketing and management activities in Istanbul, manufacturing and R&D activities in Duzce and API manufacturing in Cerkezkoy having approximately 2500 employees ...

• 

  Sandoz

  • Switzerland
  • Pharmaceutical Manufacturing
  • 700 & Above Employee

  • Quality Assurance Specialist

    • Oct 2003 - Dec 2006

    < Active product Ingredient manufacturer operating in Istanbul which has GMP Certificates in Turkey, Australia and Slovenia• Creation, implementation and revision of the SOPs • Creation of personnel training program and train the personnel about SOPs• Execution of internal audits• Monitoring of Change Control, OOS (Out of Specification) and OOE (Out of Expectation) Results• Preparation of SOP index, revision and internal review of SOPs• Translation of technical documents from German to English and Turkish • Creation of validation reports with the studies of risk analysis

  • Analyst in Stability Laboratory

    • Aug 2001 - Oct 2003

    • Analysis of assay, dissolution, content uniformity of active substance, method transfer and related substances by HPLC (HP, Dionex, Waters) and UV spectroscopy• Checking the analysis reports and monitoring the results

  • Analyst in Quality Control Laboratory

    • May 2001 - Aug 2001

    • Analysis of assay, dissolution, content uniformity of active substance and related substances by HPLC (TSP) and UV spectroscopy

• 

  Izmir Provincial Directorate of Environment

  • Izmir, Turkey

  • Auditor

    • Oct 1998 - Jun 2000
    • Izmir, Turkey

    • Auditing the factories in accordance with the Environment Ministry Regulations