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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 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

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