Irina Borissova

Angestellt, Regulatory Affairs Specialist (Pharma Industry), Vitale-XD Ltd.
Tallinn, Estonia

Fähigkeiten und Kenntnisse

Experienced as a production manager in the pharmac
cost planning and controlling
knowledge of GMP
pressing and packing maschine handling and mainten
raw material supply
quality management
staff training and supervising
development and research of new products and formu
writing documentation and manuals (SOP's)
CTD/eCTD dossier
experienced in selection of primary and secondary

Werdegang

Berufserfahrung von Irina Borissova

  • Current 13 years and 1 month, since May 2013

    Regulatory Affairs Specialist (Pharma Industry)

    Vitale-XD Ltd.

    - drafting and compiling CTD and eCTD dossier; - compilation of registration documents for Russia and Belarus; - the timely amendments of the Marketing Authorization; - creation/development new formulations; - conducting process validation/ revalidation.

  • 3 years and 4 months, Jan 2010 - Apr 2013

    Production Manager (Pharma Industry)

    Vitale-XD Ltd.

    supervision/control of the production process according to GMP; ensuring that production is cost effective; making sure that the products are produced on time and in good quality; working out the human and material resources needed; estimating costs and setting the quality standards; responsible for selection/maintenance of equipment; ensuring health and safety standards; supervising and motivating a team of workers and staff training; research (formulations/products); writing technical manuals and SOP’s.

  • 4 months, Sep 2009 - Dec 2009

    Chemist-Analyst

    Vitale-XD Ltd.

    raw materials and finished product testing and retesting using HPLC and IR spectroscopy; analyze collected data; conduct of a validation process.

  • 1 year and 2 months, Jul 2008 - Aug 2009

    Product Engineer

    Elcoteq Tallinn AS

    tracking the start of production of finished goods production and release; writing technical manuals and SOP’s; data collection to ensure the smooth running; staff training

  • 8 months, Nov 2007 - Jun 2008

    Troubleshooter (Nokia phones line)

    Elcoteq Tallinn AS

    work with the semi products and final products; find errors and make repairs.

  • 3 years and 4 months, Jul 2004 - Oct 2007

    Head of operator BGA

    Elcoteq Tallinn AS

    soldering with BGA (Ball Grid Array) machine; staff training.

Ausbildung von Irina Borissova

  • 4 years and 10 months, Sep 2003 - Jun 2008

    Faculty of Chemical and Materials Technology

    Tallinn Universtity of Technology

Sprachen

  • Russian

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • Italian

    A1-A2 (Grundkenntnisse)

  • German

    A1-A2 (Grundkenntnisse)

  • Finnish

    A1-A2 (Grundkenntnisse)

  • Estonian

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