Experience

Novartis in Slovenia

• Slovenia
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• QA Senior Manager ESO FDF

  • Dec 2022 - Present

• QA Manager ESO FDF

  • Oct 2021 - Dec 2022



Krka

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory affairs associate

  • Nov 2018 - Oct 2021

  Planning, coordination of the writing and reviewing for Module 2 - 5 CTD sections in accordance with national requirements depending on the marketCollect and / or create country specific documents for regulatory filings worldwideResponse to questions raised by authoritiesEnsure continued regulatory compliance of products though adherence to the change control procedures and completion of regulatory impact assessmentsProvide regulatory support to ensure the content of dossier is compliant with relevant regulations and is sufficient for submission/notification

• QA professional associate

  • Oct 2017 - Nov 2018

  Quality management at CMO, responsible for solid dosage forms. Monitoring compliance with allGXPs and relevant standards and guidelines, management of deviation with CMO and within Krka,management of complaints to CMO, evaluation and preparation of Annual Product Review, planning and executing quality assurance activities including documentation, participation in various projects,inspections and audits.

• QA professional associate

  • Jul 2016 - Oct 2017

  Quality management, QA Incoming materials, Quality assessment of Raw materials:responsible for the receipt, inspection, sampling, and release of active pharmaceutical ingredients and raw materials (SAP), communicating with internal laboratories to adhere to testing schedule, collaboration with production sites in solving problems in relation to quality, GMP or GDP,responsible to research deviation in production and quality control processes, managing complaints, review and assess supplier CAPA reports, coordination of the elimination established nonconformities.



Lek d.d., a Sandoz company

• Assistant at Medical Research department

  • Oct 2014 - Mar 2015

  Managing various engines and databases (NKC, Ovid Medline, EMBASE; TOXNET, Cortellis ...), preparing summaries from databases about clinical and non-clinical recent studies. Review and revision of Summary of Product Characteristics and Patient Leaflets. Editing the data and documents of toxicological studies. Translation of documents slo-eng, eng-slo. Responsible for department archive. Managing various engines and databases (NKC, Ovid Medline, EMBASE; TOXNET, Cortellis ...), preparing summaries from databases about clinical and non-clinical recent studies. Review and revision of Summary of Product Characteristics and Patient Leaflets. Editing the data and documents of toxicological studies. Translation of documents slo-eng, eng-slo. Responsible for department archive.

• Lab technician

  • Oct 2013 - Mar 2014

  Rheology, nanotechnology; analytical observation of samples, knowledge of laboratory equipment and devices, knowledge of safe work, environmental protection and our protection, preparation of reagents, data collection and analysis, use of different equipment (photon correlation spectroscopy - Zetasizer, lyophilizer, centrifuge, ultracentrifuge, rheometers and viscosimeters and few other simpler accessories). Rheology, nanotechnology; analytical observation of samples, knowledge of laboratory equipment and devices, knowledge of safe work, environmental protection and our protection, preparation of reagents, data collection and analysis, use of different equipment (photon correlation spectroscopy - Zetasizer, lyophilizer, centrifuge, ultracentrifuge, rheometers and viscosimeters and few other simpler accessories).