
Irina Borissova
Fähigkeiten und Kenntnisse
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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