Andrii Kosikov
Address //
Cell: +3 8 (063) 458 00 18;
Skype: Andrii.Kosikov
Email: andeikosikov@gmail.com
Validation Manager
Profile:
• Three years of experience in positions of validation manager
• Experience in drug manufacture validation and cold chain validation
• Ability to manage a team of professionals
• In-depth knowledge in Commissioning, Qualification, Quality, Regulatory Compliance Rules of GMP, GDP, Validation Projects Management
• Big knowledge in GMP audits
• Exceptional knowledge of all pharmaceuticals rules and standards
• Outstanding understanding of validation principles
• Good ability in planning of work
• Huge knowledge in data collection
• Skilled in creation of validation protocols and SOPs
• A lot of experience in using different validation equipment
• Vast knowledge in writing analysis and review
• Excellent write and speak skills
Technical skills:
• Validation equipment: particle counter “Solair” 5100, 3100; different models of the balometers, anemometers, differential manometers; equipment for air visualization; humidity/temperature loggers; station for temperature calibration; bacteriological air sampler; microbiological equipment
• Computer programs: Microsoft Office 2013 (advanced level), Totallab TL120, Adobe Photoshop CS6, AutoCad 2014, Microsoft Project
Professional experience:
2012 – Present Validation Manager, “FARMPRO”, Kyiv, Ukraine
• Planning qualification cycle;
• Organizational work, necessary to qualification (rent equipment, search for subcontractors)
• Development of validation documentation for customer objects;
• Chef supervision for conducting of qualification;
• Coordination and approval of validation reports;
• Pre-commissioning works of HVAC systems;
• Certification of HVAC systems;
• Coordination and execution of validation reports;
• Conducting pre-commissioning of HVAC systems;
• Designing of SOPs
2009 – 2011 Engineer, Institute of Microbiology and Virology behalf Zabolotnogo National Academy of Science of Ukraine, Kyiv, Ukraine.
• Planning, preparation and staging experiments in the context of writing a research paper on the topic "Features of Pseudomonas aeruginosa biofilm formation»;
• Development and adaptation of specialized research techniques for the study of biofilm formation;
• Analysis of the results;
• Writing scientific papers for publication:
• Translate articles from English to Ukrainian;
• During the work, there were written and published 26 abstracts in the collections of international and national conferences, as well as an article in the Microbiological Journal
Completed projects:
“Kyiv Vitamin Factory”, Kyiv, Ukraine - pre-commissioning works with followed qualification of clean rooms and HVAC systems of 2 workshops
“Immunolog”, Vinnitsa, Ukraine - pre-commissioning works with followed qualification of clean rooms and HVAC systems of 2 workshops;
- qualification of 3 pharmaceutical warehouses;
- qualification of 11 cooling chambers;
- qualification of 2 autoclave;
- qualification of 2 dry heat oven;
- qualification of 1 laminar module;
- qualification of 1 cabinet of biological safety
“FarKos”, Kyiv, Ukraine - qualification of clean rooms and HVAC systems of 3 workshops; - qualification of 3 pharmaceutical warehouses;
- qualification of 1 climate chamber;
- qualification of 1 cooling chamber;
- qualification of 1 tablet press;
- qualification of 1 capsule machine;
- qualification of 1 drying cabinet;
- qualification of 1 blister packing machine;
- qualification of 2 technological processes
“Kreoma pharm”, Kyiv, Ukraine- qualification of clean rooms and HVAC systems of 6 workshops
“Valartin Pharma LLC”, Kyiv, Ukraine - pre-commissioning works with followed qualification of clean rooms and HVAC systems of 2 workshops
- qualification of clean rooms and HVAC systems of 6 workshops
“Alba Ukraine”, Dnipropetrovsk, Ukraine - qualification of 1 pharmaceutical warehouse:
- qualification of 2 cooling chambers
Corporation “Arterium”, Kyiv, Lviv, Ukraine - pre-commissioning works with HVAC systems of 10 workshops
“Pharma Start”, Kyiv, Ukraine - pre-commissioning works with HVAC systems of 3 workshops
Education:
2013 “Pharmaceutical manufacture validation”, “Group of the companies Vialek”, Moscow, Russia
2012 “Clean rooms and HVAC systems: GMP requirements”, “Ukr Med Sert”, Kyiv, Ukraine
2011 – 2012 “Environmental Biotechnology and Bioenergetics”, Master’s degree (distinction), National University of Food Technologies (NUFT), Kyiv, Ukraine
2007 – 2011 “Pharmaceutical Biotechnology”, Bachelor degree, National University of Food Technologies (NUFT), Kyiv, Ukraine