Experience

Sotex
• 1 - 100 Employee
• Production Director

  • Sep 2022 - Present
• Project Quality Manager

  • Sep 2021 - Present


Self Employed

• Real Estate
• 1 - 100 Employee

• Quality Assurance Support

  • May 2021 - Sep 2021

  Consulting and improvement in quality areas Consulting and improvement in quality areas



Rafarma

• Spain
• Software Development

• Head of Manufacturing

  • Sep 2020 - Feb 2021

  • Responsible for the production of sterile and non-sterile forms (liquids, powders, lyophilizates, solids) including antibiotics and high toxic products. • Market demand ensuring for antibiotics due to the COVID-19 situation, increasing volumes in two times. • Responsible for the production of sterile and non-sterile forms (liquids, powders, lyophilizates, solids) including antibiotics and high toxic products. • Market demand ensuring for antibiotics due to the COVID-19 situation, increasing volumes in two times.



Takeda Pharmaceuticals

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Site Quality Head

  • Mar 2016 - Aug 2020

  • Quality management (quality assurance, quality control, quality system and compliance, quality service and improvement, validation).• Improvement of key quality indicators at the required level• Replace and launch quality electronic systems (EQMS, TrackWise, LEADs).• Successful passing inspections of the Russian Federation, Kazakhstan, ISO 9001 certification bodies.• Site participation in joint training programs with State Institute of Drugs and Good Practices (Russian GMP authorities) for the Russian and EAEU inspectorate.• The company's foreign production sites support during GMP inspections by Russian regulatory authorities.• Implementation of Agile program and Best Practice Sharing in Quality Show less

• Site Head

  • Dec 2018 - Aug 2019

  Acting Site Head



Sanofi-Aventis Vostok

• Site Quality Manager

  • Aug 2013 - Mar 2016

  · Quality management (quality assurance, quality control). Maintenance Quality performance indicators. · Development, maintenance, and improvement of the quality system at the plant (CAPA/ deviation, change control, documentation, etc) · Launching new modules of quality electronic systems (Phenix), electronic document system (GEODE+) implementation. · Obtaining of GMP Certificate by the European Medical Agency (EMA). · Quality management (quality assurance, quality control). Maintenance Quality performance indicators. · Development, maintenance, and improvement of the quality system at the plant (CAPA/ deviation, change control, documentation, etc) · Launching new modules of quality electronic systems (Phenix), electronic document system (GEODE+) implementation. · Obtaining of GMP Certificate by the European Medical Agency (EMA).



Veropharm

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Head of Quality Department

  • Jan 2012 - May 2013

  • General management of Veropharm Quality Department and its subsidiary LENS-Pharm (4 branches in Voronezh city, Belgorod city, and Volginsky village).• Implementation of planning and organization of quality department activities in accordance with the requirements of GxP and ISO (9001, 13485) and the company strategic goals.• Part of the project team of new Veropharm and LENS-Pharm production facilities construction.

• Head of QC, QA Specialist, Lab Technician

  • Jul 2004 - Dec 2011

  Head of QC• Management of Quality Control department (provision of Analytical and Microbiological laboratories, vivarium, in-process control), monitoring compliance with the requirements of regulatory documents for the manufacture of drug products, API, medical devices, cosmetics, on the basis of the data to decide on the possibility of release to market, approving of raw materials.• Participation in the development and implementation of new projects and technology/development, implementation and maintenance of the quality management system of the branch, internal audits and audits of raw material suppliers, creation of lectures and designing staff training programs, and giving lectures personnel on GMP, ISO.QA Specialist:• Development of standard operating procedures, carried out of self-inspection, complaints handling, qualification of raw material suppliers, document management, training specialist substitution - designing training programs and giving lectures to personnel, selection and contracting of training with outside organizations, an annual certification (business staff assessments), provide training. Show less


Rosmedpreparaty, Russia
• BACTERIOLOGIST

  • Sep 2001 - Sep 2003