Irina Borissova

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

Tallinn, Estland

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

  • Bis heute 11 Jahre und 1 Monat, seit Mai 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 Jahre und 4 Monate, 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 Monate, Sep. 2009 - Dez. 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 Jahr und 2 Monate, Juli 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 Monate, Nov. 2007 - Juni 2008

    Troubleshooter (Nokia phones line)

    Elcoteq Tallinn AS

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

  • 3 Jahre und 4 Monate, Juli 2004 - Okt. 2007

    Head of operator BGA

    Elcoteq Tallinn AS

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

Ausbildung von Irina Borissova

  • 4 Jahre und 10 Monate, Sep. 2003 - Juni 2008

    Faculty of Chemical and Materials Technology

    Tallinn Universtity of Technology

Sprachen

  • Russisch

    Muttersprache

  • Englisch

    Fließend

  • Italienisch

    Grundlagen

  • Deutsch

    Grundlagen

  • Finnisch

    Grundlagen

  • Estonian

    -

Interessen

Travelling
Hiking
Sport (fitness)
Musik (playing piano)
Reading
Baking

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