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Специалист по контролю качества
Старший менеджер по обеспечению качества (фармацевтика)
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Хорин Андрей

Старший менеджер по обеспечению качества (фармацевтика)

Киев • 33 года

Senior quality assurance engineer в Farmak

9 лет 7 месяцев

Validation engineer в Farmak

8 месяцев

Validation engineer в Biofarma

9 месяцев

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Занятость:

Полная

Ключевая информация:

Working with leading european consultants, supporting international audits from Poland and Croatia in risk management field. 

Work in team that successfully achieved European GMP certificates for our company.

Опыт работы:

  • Senior quality assurance engineer

    сент. 2014 - н/в

    Farmak

    Responsibilities:

    • Deviations and recalls management (OOS, OOT, OOE)
    • Documentation development (nonconformances investigation reports)
    • Working with product batches documentation
    • Working with quality department documentation (specification, procedures etc)
    • CAPA-plan development and implementation
    • Development approaches for quality management system improvement
    • Development and Integration of Risk management system into company processes
    • Quality management system effectiveness analysis and system supporting in accordance to FDA guidance for industry requirements: Q10
    • working with Medical Devices Risk Management system in accordance to ISO 14971
    • Participating in external audits, performing suppliers audits

  • Validation engineer

    янв. 2014 - сент. 2014

    Farmak

    Validation documentation development, such as:

    • DQ/IQ/OQ/PQ protocols and reports, Validation master plan
    • Development URS Requirements for FAT, SAT
    • Performing SAT/FAT
    • Equipment and utilities validation

  • Validation engineer

    марта 2013 - дек. 2013

    Biofarma

    Equipment and utilities validation.


    Development of validation documentation, such as:

    • DQ/IQ/OQ/PQ protocols and reports.
    • Validation master plan.
    • URS.

    Develop requirements for FAT, SAT.

    Performing factory acceptance tests for filling and capping equipment, sterilization tunnels, moist heat sterilization equipment, vials, ampoules and bottles washing machines, syringes filling machines, labeling and package equipment.

    Working in Italy as a leader of FAT-group of plastic bottles filling and labeling line (Bologna, Marchesini Group), and a member of FAT-groups in Siena (Neri), Florenzia (Co.Ri.MA).

Образование:

  • National University of Food Technologies (Kiev)

    Год окончания 2013

    Pharmaceutical biotechnology, Specialist

  • VIALEK (Kyiv, Ukraine)

    Год окончания 2015

    Certificate "Deviation management and change control, including ICH Q10 requirements"

  • ETALON (Kyiv, Ukraine)

    Год окончания 2015

    Certificate "Quality Management systems according to ISO 9001:2009, ISO 22000:2005, ISO 13485:2005 and risk management according to ISO 14971:2009" from 08-10 June 2015

  • ETALON (Kyiv)

    Год окончания 2015

    Certificate "Methodology of identification and analysis hazard factors, planning corrective and preventive actions, according to HACCP with compliance of ISO 22000:2007

  • VIALEK (Kyiv, Ukraine)

    Год окончания 2015

    Certificate "Quality Risk management" - Gratitude for presenting of practical approaches into using of risk instruments FMEA and RRF in pharmaceuticals industry on international conference

  • ETALON (Kyiv, Ukraine)

    Год окончания 2015

    Certificate "Internal audit of food products safety management system in accordance to ISO 19011:2012:

Дополнительно:

Language skills:

  • English - upper intermediate (I can be interviewed in this language);
  • Russian - native (I can be interviewed in this language);
  • Ukrainian - native (I can be interviewed in this language).


Computer Skills and Additional information:

  • Risk design space modelling and consulting.
  • Performing quality assurance training.
  • Project management.
  • Development Risk based approaches into math based trend analysis (including statistical analysis of analytical methods, periodic quality review, validation and qualification tests amount, equipment maintenance).

 

Free user: SAP, Infotehna, AutoCAD.


Preferred branches: quality management, validation (equipment and utilities), technology support. Willing to consider other proposals.


Objective: Obtain position in quality management or validation (equipment and utilities), or technology support department in international pharmaceutical company.

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