Barbara P.
Quality Assurance Specialist at Selvita- Claim this Profile
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English Full professional proficiency
Topline Score
Bio
Credentials
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Good Clinical Practice ICH-GCP E6 (R2)
Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center)Apr, 2023- Nov, 2024 -
Good Manufacturing Practice Quality Assurance
SUPERA KVALITETA d.o.o.Dec, 2021- Nov, 2024 -
Good Clinical Practice ICH-GCP E6 (R2)
AACI AmericaApr, 2021- Nov, 2024 -
GLP and Quality Assurance: Developing a GLP Compliant QA Program
CfPA - The Center for Professional AdvancementMay, 2019- Nov, 2024
Experience
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Selvita
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Poland
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Biotechnology Research
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500 - 600 Employee
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Quality Assurance Specialist
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Apr 2022 - Present
- Participation in the Quality Management System, in generation of scientific and general documentation, the coding practices, their distribution, review and approval process - Conduct of internal Quality Assurance inspections - Conduct Quality Assurance program in accordance with the Principles of GLP/GCP (performed Study-based, Facility-based and Process-based inspection) - Oversee and participated in GxP inspections and other regulatory inspections - Control and distribution of all controlled documents SOPs, forms, laboratory notebooks - Performed and participated in internal/external inspections/audits - Create standard operating procedures for QA activities - Quality control, reviewing Research Reports, Study Reports - Monitoring implementation of corrective measures in all organizational units of the Company Show less
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Fidelta
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Croatia
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Biotechnology Research
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1 - 100 Employee
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Quality Assurance Associate
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Jun 2019 - Mar 2022
- Participation in the Quality Management System, in generation of scientific and general documentation, the coding practices, their distribution, review and approval process - Conduct of internal Quality Assurance inspections - Conduct Quality Assurance program in accordance with the Principles of GLP/GCP (performed Study-based, Facility-based and Process-based inspection) - Oversee and participated in GxP inspections and other regulatory inspections- Control and distribution of all controlled documents SOPs, forms, laboratory notebooks- Performed and participated in internal/external inspections/audits- Create standard operating procedures for QA activities- Quality control, reviewing Research Reports, Study Reports- Monitoring implementation of corrective measures in all organizational units of the Company Show less
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Quality Assurance Assistant
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May 2016 - Jun 2019
- Participation in the Quality Management System, in generation of scientific and general documentation, the coding practices, their distribution, review and approval process - Monitoring implementation of corrective measures in all organizational units of the Company - Participation in conduct of internal QA inspections - Control and distribution of laboratory notebooks- Participation in inspections performed by relevant regulatory and other institutions - Participation in activities ensuring the Company's compliance with the corporate quality guidelines Show less
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Sales Promoter
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Jun 2014 - Dec 2014
Promotion Bioderma and ESI products in Farmacia. Promotion Bioderma and ESI products in Farmacia.
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Sales Promoter
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Jul 2013 - Aug 2013
Promotion of their products. Promotion of their products.
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Croatian Institute of Public Health (Hrvatski zavod za javno zdravstvo - HZJZ)
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Croatia
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Hospitals and Health Care
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100 - 200 Employee
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Student
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Aug 2012 - Sep 2012
Object of Common Use and Medical Device Department, for the purpose faculty practice. Object of Common Use and Medical Device Department, for the purpose faculty practice.
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Education
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2022 -
University of Zagreb, Faculty of Chemical Engineering and Technology
Doctor of Philosophy - PhD Student -
2013 - 2015
University of Zagreb, Faculty of Chemical Engineering and Technology
Master's degree, Analytical Chemistry -
2009 - 2013
University of Zagreb, Faculty of Chemical Engineering and Technology
Final thesis: Determination of physico-chemical properties of pharmaceuticals, Analytical and Organic Chemistry -
2005 - 2009
Zdrastveno Učilište Zagreb, Zagreb Health School
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