Experience

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  Hemofarm a.d.

  May 2003 - Jun 2019

  - External audits process management - planning, realization,- Using risk assessment and operational excellence tools to optimize audit planning process- Training of new external auditors- Performing external audits of manufacturers of finished pharmaceutical products, APIs, excipients, packaging material, critical materials, contract laboratories and other outsourced companies – up to now lead auditor in more than 100 audits- Expert in usage of root cause investigation tools and risk assessment approach to identify GMP gaps and possibilities for quality system improvement- Preparation of SOP's, risk assessments and other QMS documents- QA team member in various projects in pharmaceutical industry, including complex projects like acquisition of other companies and their integration in quality system, startup of new plants and their preparation for successful EU GMP inspections etc- SAP validation team member – preparation and review of SAP validation documents Show less - Coordination of all inspections of Hemofarm by external institutions, i.e. domestic and foreign drug authorities (EU inspections, US FDA, TGA, authorities from Russia, Ukraine, Azerbaijan, Turkey, South Korea etc) - External audits planning and realization- Performing external audits of manufacturers of finished pharmaceutical products, APIs, excipients, packaging material, critical materials, contract laboratories and other outsourced companies – lead auditor in more than 100 audits- Selfinspection planning and realization- Monitoring of aseptic operators in sterile production in accordance with Best Aseptic Practice- GMP qualification and requalification of suppliers and contract partners- CAPA process management- Expert in usage of root cause investigation tools and risk assessment approach to identify GMP gaps and possibilities for quality system improvement- Preparation of QA SOP's, training of employees- SAP validation team member – preparation and review of SAP validation documents- QA team member in various projects in pharmaceutical industry, including complex projects like acquisition of other companies and their integration in quality system, startup of new plants and their preparation for successful EU GMP inspections etc Show less

  • Audit Specialist

    Aug 2018 - Jun 2019

  • Head of Internal and External Audits Department

    Oct 2007 - Aug 2018

  • Independent Expert Associate for Internal and External Audits

    Jan 2007 - Oct 2007

  • Expert associate for environmental protection

    May 2003 - Dec 2006
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  Novartis

  Jun 2019 - Oct 2023

  Ensures that all aspects of the operational business for key biopharmaceutical products at strategic external supplier sites comply with international standards of cGMP, regulatory requirements, the Novartis Group Quality Manual and Quality Directives and the applicable Quality Agreements Ensures that all aspects of the operational business for key sterile pharmaceuticalproducts at strategic external supplier sites comply with international standards of cGMP, regulatory requirements, the Novartis Group Quality Manual and Quality Directives and the applicable Quality Agreements

  • Senior QA Manager in Innovative Medicines Large Molecules ESO

    Oct 2020 - Oct 2023

  • Senior QA Manager in ESO Division

    Jun 2019 - Oct 2020
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  Sandoz

  Oct 2023 - now

  Senior qa manager