Jurate Zundiene

Experience

• 

  Vilnius University, Institute of Biotechnology

  Oct 1998 - Jun 2000

  Laboratory Assistant

  Participation in R&D development projects. Purification of proteins from initial recovery to filling of active pharmaceutical ingredients (API) formulation for R&D purposes.

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  Sicor Biotech UAB / TEVA group, Vilnius

  Aug 2000 - Sept 2011

  Management and coordination of company R&D investigational projects activities with projects owners from projects initiation step (preparation of projects proposals, development plans, allocation of employees per projects, participation in calculation of projects budget) till projects completion step (preparation of projects Progress Reports, organization and leading of teleconferences and meetings with projects owners, preparation of projects Final Reports, monitoring of investigational medicine products stability studies) according to cGLP/cGMP guidelines. Active participation in establishment of GLP requirements in R&D Department. Daily communication with projects owners and R&D projects teams, solving problems, updating projects plans, reallocation of employees, making decisions, reporting to company management. Participation in preparation of CMC parts of Investigation Medicinal Product Dossier (IMPD).Organizing produced GLP material supply for pre-clinical, Phase I-III clinical trials studies. Show less

  • Projects Manager / Coordinator

    Jul 2004 - Sept 2011

  • Technologist

    Aug 2000 - Jul 2004
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  Biotechpharma UAB

  Sept 2011 - Dec 2014

  Quality Assurance Manager

  Implementation and constant improvement of EU and US GMP requirements in GMP Facility and GLP requirements in R&D Department. Preparation / review and authorization of standard operating procedures (SOP), batch production records (BPRs), testing protocols, specifications, stability protocols and reports, instructions and all QA related documents of the company according to Good documentation practice (GDocP). Monitoring site quality performance - Quality metrics (e.g. change controls, deviations, corrective and preventive actions (CAPAs), out of specifications (OOS), complaints and etc.). Performance of routine training of company employees and customers / visitors, conducting internal audits as well as leading external audits of customers from EU and US. Preparation of CAPA plans for implementation of audits observations. Monitoring of critical systems / equipment validation and Quality Control activities. Make decisions on suitability (released / rejected) of intermediates, active pharmaceutical ingredients (API) and drug products (DP) for pre-clinical, Phase I-III clinical trials, commercial use. Participation of evaluation of new projects at R&D stage and/or GMP stage, preparation of proposals and discussions with potential customers. Monitoring of company projects in order to ensure that all activities are performed according to GLP / EU and US GMP requirements and manufactured material could be released for pre-clinical, Phase I-III clinical trials, commercial use. . Active participation in preparation of CMC parts of Investigation Medicinal Product Dossier (IMPD) and Common Technical Document (CTD): Module 2.3 (Quality Overall Summary) and Module 3 (Quality) for European Marketing Application Authorizations (MAA). Show less

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  Profarma UAB

  Dec 2014 - Mar 2018

  Head of Quality Unit

  Quality Assurance, Quality Control and Maintenance/validation activities according to GMP requirements.

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  Biotechpharma UAB

  Dec 2018 - Dec 2022

  Business Development Manager

  Working with team to develop Projects Proposals that speaks to the Client’s needs, concerns, and objectives.

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  Thermo Fisher Scientific

  Sept 2024 - now

  Sr. QA specialist