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Experiences

Current Experience

  • Expert Associate in Investigation Management Department
    Since October 2016
    Responsibilities: - Process deviations and customer complaints managing (investigation and determination of root cause, defining corrective and preventive actions and monitoring the implementation of the prescribed measures) - Participation in FDA, PIC/s, EU and local regulatory inspections and audits - Frequent communication with external laboratories and contract partners (outsourced activities) - Preparing SOPs and Working Instructions, training of the employees in accordance with relevant procedures - Preparing of annual product review (deviations, complaints, CAPA) - Preparing monthly and annual reports and presentations

Past Experience

  • Expert associate in Product Quality Review Department
    May 2013 --- October 2016
    Responsibilities: - Preparing of annual product review - Process deviations and customer complaints managing (investigation and determination of root cause, defining corrective and preventive actions and monitoring the implementation of the measures) - Participation in regulatory inspections and audits - Preparing SOPs and Working Instructions, training of the employees in accordance with relevant procedures - Preparing monthly and annual reports and presentations - Frequent communication with external laboratories and contract partners (outsourced activities), preparing Quality contract agreements

  • Research associate
    November 2011 --- June 2012
    - PAT techniques - NIR Spectroscopy - Pellets production - Preparing feasibility study for capability of the in-line NIR spectroscopy for determination of solvents remains in wet cores drying procedure and determination of pellets size distribution and coating thickness in pellets coating procedure - Acquisition of NIR spectra during pellet coating of regular production batches, sampling and analyzing of referent samples in IPC laboratory - Modeling and developing the calibration equations for NIR models by using PLS regression method - Re-calculation of all tested batches according NIR models to define process parameters to enable monitoring of those parameters in real time

Knowledge

LinkedIn Assessment :
Pharmaceutical IndustryPharmaceuticsGMPBiotechnologyChemistryValidationMicrosoft OfficeResearchTeam LeadershipSOPAnalytical ChemistryRegulatory affairsEnglishTechnology transferLifesciencesScientific WritingChemical EngineeringPharmacueticalsChromatographyMicrobiologyBiochemistryHPLCPharmacovigilancemolecular biologyScience CommunicationLife SciencesStandard Operating Procedure (SOP)ToxicologyUV/VisProcess SimulationQuality by DesignFormulationSAP

Skills and Expertise

Self Assessment :
Quality control processReview quality control activitiesManage Quality Management System (QMS) documentationFollow-up of quality assurance activitiesLead teamsLiaise with research team in order to accurately collect and record dataPrepare internal auditsPrepare external auditsgmpGDP

Education

  • in Student exchange - internship from Biotechnical Faculty, University of Ljubljana in 2012
  • Master of Science (MSc) in Pharmaceutical engeneering from Faculty of Technology, University of Novi Sad in 2012
  • Local BEST Group Stockholm in Summer Course, S(t)imulating life: from CPU to your stomach from KTH Royal Institute of Technology in 2011
  • in Summer Course, Advanced Separation Technologies in Chemical Engineerin from Technische Universität Berlin in 2010

Languages

BrightOwl Assessment:
Self Assessment:
Serbian
Native
Croatian
Native
SLOVENIAN
Professional Proficiency
English
Professional Proficiency

Work Preferences

  • Positions I am interested in:
    Associate Scientist Compliance Manager Engineer Field Project Manager Industrial Pharmacist Junior Consultant Process Engineer QA Consultant QA Engineer QA Officer Quality Assurance (QA) Manager Quality Engineer Quality manager Research Assistant
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    full time% FTE
    BrightOwl freelancer
    BrightOwl employee :    full time% FTE
  • International:
    Yes

Area / Region

Novi Sad, Vojvodina

Others

Driving License
  • Yes