Profile: Skilled in Verification and Validation (V&V), Cleaning Validation, Validation, GMP, ISO 9001, and Pharmaceutical Industry. Completed audits as lead auditor (2019 – 2023): Good Manufacturing Practice (GMP): 56 audits (e.g. Aurobindo, Steril Gene, SoftGel, VerGo, Aurovitas China, Mylan, Synthon, Accord, Generis, Dexcel, Granules India, RK Pharma etc.) - Eudralex, Volume 4, Annex 14, Manufacture of Medicinal Products Derived from Human Blood or Plasma: 30 audits (Grifols in Czech Republic and Slovakia) - Good Distribution Practice (GDP): 6 audits (UniPharma, Movianto SK, Movianto CZ, Phoenix Hungary, Phonix CZ, Alliance Healthcare) - Good Vigilance Practice: 4 audits (Acrotech US). Trainings done are for Cleaning validation (2010) • ILeadership – communication with team, method of team managing, meeting leadership, time management (2018) • Course of qualified person of drug manufacturer – finished by certified exam of the Qualified Person (2019 – 2020) • Certification course of ISO 9001 Lead auditor (Chartered Quality Institute & International Register of Certificated Auditors, Great Britain), 2021 • Certification course of GMP+ B3 (Trade, storage and shipment of feeds) and B4 (Feeds Transport) Lead auditor, 2021. Knowledge of foreign language • English Advanced • Russian Upper-intermediate. Another skills and knowledge • PC user’s level (Word, Excel, PowerPoint, Access, database systems). Audit mainly pharma sites in Euroupe, India and China. Based in Czech Republic.