Artem Kochenov
Specialist Csv & It-grc @OECHSLER
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WORK HISTORY
Specialist Csv & It-grc @OECHSLER
DE
Process Development: Acted as a subject matter expert and led the development of a complete Computerized System Validation (CSV) framework from the ground up, in alignment with GAMP 5 and a risk-based validation approach, including all required SOPs, policies, and technical documentation.Validation Strategy: Led the end-to-end software validation lifecycle, from risk assessment and system classification through IQ/OQ/PQ execution and final validation reporting, ensuring computerized systems were fit for intended use and compliant with ALCOA+ data integrity principles.Digital Governance: Actively participated in company-wide digitization and IT governance activities, contributing expert guidance on CSV-relevant IT processes, data integrity, access control, and change management, in alignment with GxP and 21 CFR Part 11 requirements.Audit Readiness: Led and managed audit preparedness activities for ISO 13485 and FDA (21 CFR Part 11) inspections, ensuring sustained compliance of computerized systems and successful audit outcomes.
EDUCATION
International Center for Molecular Physiology of National Academy of Sciences of Ukraine
Doctor of Philosophy - PhD, Biophysics
Oles Honchar Dnipro National University
Master's degree, Biotechnical and medical devices and systems
ABOUT ARTEM KOCHENOV
As a CyberOps Course Developer at Cyber Security Forum Initiative, I leverage my expertise in cybersecurity and HUMINT to create comprehensive training courses and materials for individuals and organizations. I volunteer my time to this non-profit organization because I am passionate about educating and empowering others to combat cyber threats and protect their data and privacy. With over two years of experience as a Head of HUMINT and Senior Analyst at Molfar, a leading competitive intelligence firm, I managed and organized the work of the department, conducted strategic and tactical planning, handled lectures and workshops, negotiated with clients, and developed and implemented work instructions and manuals. I also have a strong background in biophysics, with a PhD and a Master\'s degree in related fields, and multiple publications in scientific journals and passionate about biotechnologies, with a keen interest in exploring advancements related to lifespan, healthspan, and longevity. I have completed several edX courses in statistics, neuroscience, and personal improvement, demonstrating my commitment to lifelong learning and self-development. I am a team player, a mentor, and a leader, who can easily immerse myself in a new topic or area of interest and adapt and learn all that I need for a new role. I am looking for opportunities to apply my skills and knowledge in the realms of medical, analytical, intelligence, and cybersecurity domains, and to collaborate with like-minded professionals who share my values and goals. Let\'s connect and explore the intersections of science, education, and innovation together!
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