Ivan Giba

Head of Quality Department at GEROPHARM
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Contact Information
us****@****om
(386) 825-5501
Location
St Petersburg, St Petersburg City, Russia, RU
Languages
  • Russian Native or bilingual proficiency
  • English Professional working proficiency

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Credentials

  • Qualified Person. Advanced training
    Санкт-Петербургская Государственная Химико-Фармацевтическая Академия
    Apr, 2022
    - Nov, 2024
  • Auditing according ICH-GCP
    QUINTA-ANALYTICA
    Oct, 2021
    - Nov, 2024
  • Quality Assurance for Good Laboratory Practice
    Research Quality Association (RQA)
    Apr, 2021
    - Nov, 2024
  • Разработка, внедрение и поддержание системы менеджмента лабораторий – концепция стандарта ГОСТ ISO/IEC 17025 и Критериев аккредитации (приказ Минэкономразвития № 707)
    УЦ ООО "ЛЕММА"
    Apr, 2021
    - Nov, 2024
  • Применение риск-ориентированного подхода к изучению стабильности лекарственных препаратов и АФС
    ФБУ «ГИЛС и НП» и ООО «Фармстратегия»
    Jan, 2021
    - Nov, 2024
  • Good clinical practice, ICH GCP E6 (R2)
    Clinical Trials Medical Center UNINOVA
    Nov, 2020
    - Nov, 2024
  • Переход на евразийские правила GMP. Риск-ориентированный подход в отношении управления целостностью данных
    ФБУ «ГИЛС и НП» и ООО «Фармстратегия»
    Nov, 2020
    - Nov, 2024
  • Правовые основы инспектирования в ЕАЭС. Виды инспекций. Правила инспектирования и последующий контроль. Постинспекционные действия. Порядок выдачи, приостановления и прекращения действия сертификата. Совместные фармацевтические инспекции
    ФБУ «ГИЛС и НП» и ООО «Фармстратегия»
    Nov, 2020
    - Nov, 2024
  • The requirements of ISO 9001:2015 Quality Management Systems. Internal Auditor
    Bureau Veritas Group
    Dec, 2019
    - Nov, 2024
  • Manufacture of sterile pharmaceutical products
    Учебный Центр ВИАЛЕК
    Mar, 2019
    - Nov, 2024
  • Modern EU and FDA Validation: Ongoing/Continued Process Verification from Control Strategy to Product Quality Review
    ECA Foundation & ECA Academy
    May, 2018
    - Nov, 2024
  • Qualified Person
    Санкт-Петербургская Государственная Химико-Фармацевтическая Академия
    Oct, 2021
    - Nov, 2024

Experience

  • GEROPHARM
    • Russian Federation
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Head of Quality Department
      • Mar 2021 - Present

      • Maintaining quality systems in the pharmaceutical development, ISO 17025, GLP, GCP, GVP, GMP.• Development of main quality documents: Quality Manuals (Laboratory Quality Manual, Pharmacovigilance Quality Manual, Quality Assurance Program, etc.) and Quality Politics.• Development of quality documents within the framework of internal and external transfer projects: QAAs, SOPs, etc.• Organization and conduct of first and second-party audits.• Supervision of third-party audits: CECMED, Roszdravnadzor, Federal Service for Accreditation (RusAccreditation).• Department management: formation of the department structure, development of instructions, KPIs, cross-functional interaction. Show less

    • QA Specialist
      • Oct 2019 - Mar 2021

      • Development and implementation of a quality system in R&D according to ICH Q8 (R2).• Development and implementation of a quality system for in vitro preclinical studies in accordance with GLP principles.• Organization of a quality system for analytical laboratory in the framework of ISO 17025.• Conducting an external audit of vendors for in vivo preclinical studies.• Vendor audits for pharmaceutical development projects.

  • ITMO University
    • Russian Federation
    • Higher Education
    • 300 - 400 Employee
    • Associate Professor
      • Oct 2022 - Present

      Master's degree programme: 19.04.01 Biotechnology. Teaching: • Quality and safety of biotechnological products; • Development, production and distribution of drugs in accordance GxP principles. Master's degree programme: 19.04.01 Biotechnology. Teaching: • Quality and safety of biotechnological products; • Development, production and distribution of drugs in accordance GxP principles.

  • ФГУП СПбНИИВС ФМБА России
    • Saint Petersburg, Russian Federation
    • Validation Engineer
      • Aug 2018 - Oct 2019

      • Ensuring the production of the flu vaccines and serums. • Providing an overall technical supportive role in the areas of Cleaning and Process Validation. • Assisting with qualification of new equipment/controls and assists in vendor and site acceptance testing to meet engineering standards. • Coordinate validation execution between all involved departments, including Mfg, Process Engineering, Process Automation, QC, and QA. • Review/analyzing whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the FDA cGMP, EudraLex - Volume 4, PDA Technical Reports, ISPE Guides, ISO 13485, 14644, etc. • Organization and conduct of internal and external audits; • Conduct risk analysis using FMEA, HACCP, FTA, RRF; • Providing oversight/coaching /mentoring/training to other engineers. Show less

  • BIOCAD
    • Russian Federation
    • Pharmaceutical Manufacturing
    • 500 - 600 Employee
    • Junior QA Specialist
      • Dec 2017 - Aug 2018

      • Support and provide input to Validation Master Plan for process validation, cleaning validation and transportation validation.• Partner with Production, Engineering, QC and Quality to define the process validation, cleaning validation and transportation validation interface. • Manage the respective validation plans by aligning, coordinating, supervising and executing the activities. Authors risk assessments for validation. • Uses local procedures & templates for respective validation documentation.• Maintain all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities. • Ensure that all Site validation activities are performed and are in line with the current company requirements and GMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes. • Responsible to translate the critical process parameters and the process control strategy into a focused validation plan for process validation. • Author validation protocols (e.g. process, cleaning, transportation). • Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation. • Lead validation related investigations and deviations. • Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures. • Understand potential risk areas/shortfalls and make sure that the validation program is always inspection ready. • Adheres to all applicable procedures, cGMPs, company policies, and any other quality or regulatory requirements (FDA, EMA, 916 ФЗ РФ, GMP ЕАЭС, PDA, etc.). Show less

    • Chemist-Technician 2nd category
      • Jan 2017 - Dec 2017

      • Performance of duties of the master on manufacture. Coordinating the work of 4 people in a working shift.• Preparation of production for licensing, according to GMP requirements. • Passage of the internal and external audits. • Preparation of specifications of user requirements (URS), development of qualification plans taking into account risk analysis, equipment validation (DQ, IQ, OQ, PQ), filling of validation protocols and reports about the conduct of qualification. • Developing SOPs for operation and maintenance of various types of equipment. • Filling technological documentation (technological maps, journals, sheets of deviations, stock-taking cards, memos, etc.). • Knowledge and work in electronic systems EQMS, ERP. Show less

    • Chemist-Technician
      • Jun 2016 - Jan 2017

      • Participation in the production of the following products: Timekson (Glatiramer acetate), Novotax (Docetaxel), Paclitaxel, Fingolimod (Gilenya). • Ensuring the maintenance of technological processes in accordance with the approved documentation.• Work with the following equipment:-Reactors: HWS, Buchi, Purui.-Tangential flow filtration (TFF) system: Millipore, Sartorius.-Freeze Dryers: Zirbus; Labconco.-Vacuum Drum Dryer: ZPD.-Thermostats: Lauda, Julabo, Huber.-Vacuum drying cabinets: Memmert, Binder.-Overhead stirrers: IKA, Heidolph.-Pumps: Peristaltic Pumps: Masterflex; Membrane Vacuum Pumps: KNF, Vacuumbrand, Edwards, НВМ; Oily vacuum pumps: Labconco; Edwards. -Spray dryers: BUCHI.-Other equipment: rotary evaporators Heidolph, ultra centrifugal mill Retsch, thermometers Fluke, electronic scales OHAUS, scrubber СПТ, pH meter Mettler Toledo, trap for drying oven Labconco, etc. Show less

  • Saint Petersburg State University
    • Russian Federation
    • Higher Education
    • 200 - 300 Employee
    • Research Specialist
      • Sep 2015 - Jun 2016

      • Studies using NMR spectroscopy in solids and fluids. Working with devices: Bruker 400 MHz WB Avance III, Bruker 500 MHz Avance III, Bruker 400 MHz Avance. • Perform rapid analysis of the composition and purity of chemical compounds, registering the spectra on nuclei 1H, 19F, 31P, 15N, 13C, 11В. • Obtaining tomographic images of objects, including MRI analysis animals (mice, rats). • Pouring liquid nitrogen and helium in the magnets of NMR spectrometers. • Studies using NMR spectroscopy in solids and fluids. Working with devices: Bruker 400 MHz WB Avance III, Bruker 500 MHz Avance III, Bruker 400 MHz Avance. • Perform rapid analysis of the composition and purity of chemical compounds, registering the spectra on nuclei 1H, 19F, 31P, 15N, 13C, 11В. • Obtaining tomographic images of objects, including MRI analysis animals (mice, rats). • Pouring liquid nitrogen and helium in the magnets of NMR spectrometers.

  • Department of Medical Biophysics, Saratov State Medical University
    • Saratov, Russian Federation
    • Lab Assistant
      • Oct 2013 - Jul 2015

      • Conducting laboratory classes on general physics and optics for 1-3 year students, including foreign ones. • Responsibility for laboratory equipment (polarimeters, microscopes, viscometers, photocolorimeters, refractometers, lasers) used by employees of the department for scientific purposes. • Conducting laboratory classes on general physics and optics for 1-3 year students, including foreign ones. • Responsibility for laboratory equipment (polarimeters, microscopes, viscometers, photocolorimeters, refractometers, lasers) used by employees of the department for scientific purposes.

Education

  • Санкт-Петербургский Государственный Университет
    Doctor of Philosophy - PhD, Physical and Mathematical Sciences
    2017 - 2021
  • Санкт-Петербургский Государственный Университет
    Master's degree, Сhemistry
    2015 - 2017
  • Саратовский Государственный Университет им. Н.Г. Чернышевского
    Bachelor's degree, Industrial chemistry
    2011 - 2015

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