Nataliia Khytrych

Experience

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  Вorshchahivskiy Chemical Pharmaceutical Plant

  Sept 2000 - Apr 2013

  Chemist of Quality control department

  ✔ Practical skills of method’s control (substance and finish products)✔ Passing of GMP certification (first GMP audit in Ukraine)✔ Supervisor of on-going studying of the stability program

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  Pharma Start

  Apr 2013 - Sept 2017

  Head of the physical and chemical laboratory of Quality control department

  ✔ Organization of full cycle of laboratory workflows ✔ Ensuring the proper performance of analytical procedures and pharmacopeia tests✔ SOP writing✔ Ensuring the updating of regulatory documentation in accordance with changes in the requirements of the State Pharmacopeia of Ukraine and Eu. Ph.✔ Agreement of analytical documentation of substances and finish products quality control before their registration by the Regulatory Authorities✔ Preparation of laboratory and staff for self-inspection, audits (including in the framework of the pre-registration audit by the Regulatory Authorities of the CIS countries) and GMP certification. Direct participation in their conducting✔ Training of staff Show less

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  Delta Medical

  Nov 2017 - Oct 2023

  Senior Regulatory Affairs Specialist

  ✔ Full cycle of variations, renewal, and new registrations procedures, from documents evaluation to approval✔ GMP recognition and GMP certification procedures✔ Preparation of a local registration documentation and dossier✔ Support and consultation of partners on issues of any level✔ Communication with competence authorities, sorting out of controversial issues✔ Samples import and passing of laboratory control during of new registration procedure✔ Lead of packaging materials (AW) coordination procedure on all stages✔ A supervisor of CoA template coordination procedure✔ SOP writing✔ Participation in external audits✔ Maintenance of internal and partner databases✔ Training of newcomers Show less

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  Polpharma UA

  Oct 2023 - now

  Manager of certification and registration

  ✔ Medicinal products -full cycle of variations, renewal, and new registrations procedures, from documents evaluation to approval✔ GMP recognition ✔ Certification of medical devices