Юрий

Yurii POHREBNIAK
23.03.1983
[відкрити контакти](див. вище в блоці «контактна інформація») (personal)
[відкрити контакти](див. вище в блоці «контактна інформація») / [відкрити контакти](див. вище в блоці «контактна інформація»)
Residence: Kyiv, Ukraine, 01133

CAREER AND EXPERIENCE
Jan.2020 – till today Alpen Pharma group of companies (Alpen Pharma AG and PJSC “Naturfarm”) www.alpenpharma.com Quality Assurance Manager
(Note: Jun.2021 – Oct.2021 – not working (accident))
Similar to the previous place and extra implementation of the integrated quality management system of the company level (eQMS project).

Nov.2017 – Jan.2020, “Farmasoft” LLC. www.farmasoft.com.ua
Deputy Director general for Quality. QP / Responsible person. Managerial position.
Quality & Compliance Specialist (5 licenses for manufacturing (repackaging), importation, wholesale and retail trade, separate license for narcotics (drugs), dangerous goods import/export permission etc., GDP certificate, ISO 9001:2015 certified).

GDР / ІSО сertification of the Company and partner audits.
Initial task was revision of the quality management system and integration with the Business Process Management System («BPMS») according to ISO 9001 and GDP requirements. This key objective was successfully accomplished.
Directly responsible for:
Maintaining ISO and GDP standards and yearly re-certification on a company level;
External audits which were requested by clients (clinical trials);
Handling claims and non-conformities reported in quality management system;
The company level documentation, development, evaluation and its up to date efficiency tracking and update (ISO and GDP requirements maintenance, documentation related to compliance, information security, processes efficiency, company level workflows maintenance);
Implementation of internal audits system and its further analysis, following-up internal audit findings with corrective and preventive actions process coordination;
Initiating, developing and maintaining processes revision, regular analyzing of optimization tasks, escalation and finalization of improvements;
Assuring effective communication and cooperation with other departments and teams in order to maintain the quality and continuous improvement of all company level processes;
Development of the Training Center in computerized system, maintaining staff awareness regarding information security and compliance matters;
Assisting with personal data protection (GDPR) regulation and required processes establishment and maintenance within the company;
Revision of the validation strategy and revalidation of the company infrastructure;
Implementation of the Key Performance Indicators system integrated with quality objectives and monitoring processes;
Enhancing quality, compliance and information security through advocacy of best practices, continuous optimization and improvement.

Aug.2006 - Nov.2017 – State Service of Ukraine on Medicines and Drugs Control (SMDC) www.dls.gov.ua
Aug.2006 – Mar.2008 – junior inspector in the regional inspectorate in Poltava district. GDP inspections and compliance inspections of heathcare institutions of all levels.
Mar.2008 – Jun.2010 – senior inspector in Head Office, Kyiv city.
internal audits of subordinated subdivisions in districts/regions, laboratories and departments. GMP/GDP/GLP inspections as a GMP/GDP Inspector, was listed in the International GMP register, developed some UA regulatory practices.
Sep.2010 – Oct.2017 directly responsible for the international regulatory affairs and international projects, most known:
PIC/S Accession. Since 2011 SMDC is PIC/S Participating Authority;
WHO pilot project on counterfeit medical products and pre-qualification program, successfully pre-qualified SAUMP Central Laboratory;
EDQM/Council of Europe. Ukraine accession to the European Pharmacopoeia;
Reference pricing and reimbursement system launch, not yet finished in Ukraine;
Medicrime convention, development, implementation, signature;
Track & Trace (GS1) information systems for medicinal products in Ukraine and the EU, not yet finished both in the EU and in Ukraine.
Personal contacts with Regulatory Authorities in the EU and ASEAN.

Jun.2010 – Sep.2010 – LLC “Sanofi-Aventis Ukraine”. www.sanofi.ua
Regulatory Department. Affiliate Quality Officer.
Quality management, GMP/GDP certification, work with the regulatory authorities, laboratories, marketing authorization, cold chain / supply chain, affiliate quality system. Have been returned on agreement between Sanofi CEO and SAUMP CEO to the state authority in order to finalize mentioned major projects.

Aug.2005 – Aug.2006 – Deputy chair of the wholesale community enterprise “Poltavafarm”, Poltava city (direction for a job from the University).
Wholesale trade of medicines, medical products, narcotics. Managerial position.
Duties: responsible for the warehouse stocks, work with suppliers and clients in regional districts, supply chain control.

Feb.2004 – May.2005 – LLC “RIDAN”, Kyiv city.
Specialist in production equipment for GMP manufacturers and medical products for tenders, documentation support.

EDUCATION / TRAINING
2008 - 2019 – GMP, GDP, GLP trainings; ISO Certified auditor; English lessons, several schools incl. diploma; International Affairs Academy and Diplomatic Academy; regulatory sections.
2000-2006 – Pharmaceutical faculty, National Medical University (Kyiv city) & National Pharmaceutical Academy (Kharkiv city). Specialist, Masters Degree.
1996-2000 – Lyceum, biology and chemistry.

KEY SKILLS
Degree in Audit. Great experience in business processes analysis and improvement.
Upper-intermediate level of English (oral and written documentation, business communication).
Ukrainian & Russian – fluent, have some publications.
Good knowledge of MS Office.
Experience with ISO 9001/27001 certification, QMS (Quality management system).
Experience in conducting internal audits (proved ISO and international GDP auditor).
Experience in work with integrated quality and management systems and further process improvement.
Experience with risk analysis implementation and development.
Understanding of GDPR, personal data protection, compliance background.

PERSONAL
Professional with quality mindset and business oriented approach.
Stress resistant and able to work with disagreements/dissatisfactions/claims from external customers and from internal teams.
Able to analyze issues with «helicopter view» and to define the best solution tackling the root cause.
Organized and flexible.
Objective and accurate in data analysis.
Strong team player.
Able to support own vision/idea with good argumentation and bring the idea to the final result.
Married, have children.