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Summary

I have many years of experience and gained knowledge in the process of manufacturing and packaging pharmaceutical formulations of all forms (aseptic production of glass ampules, glass and PVC bottles, creams and fats in tubes and all rigid forms). I also possess the knowledge to detect and resolve any deviations and inconsistencies that occur in pharmaceutical processes. I have experience in managing people and processes, as well as knowledge of "management tools" to have a positive impact on work and lessen the stress of workers. At the same time I have the knowledge and experience to implement the quality and improve the processes themselves. I participated in the creation and testing of new pharmaceutical formulations and forms. I've been running cases and taking part in direct problem solving through multi-purpose teams. I have experience in creating IQ / OQ / PQ, validation protocols and their implementation. I was working on Six Sigma implementation as well as risk assessment with several methods. Participated in internal and external audits as a member and team leader. He has participated in multifunctional teams as Quality Control, Quality Assurance Research and Development. Participated in the preparation and supervision of domestic and international inspections.

Best regards Saša.

Experiences

Past Experience

  • Manager in pharmaceutical production Varaždin, Croatia
    March 1996 --- May 2017

    2011 finished postgraduate science studies at the University of Zagreb, Faculty of Organisation and Informatics, „Business Systems Management course Corporate management, diploma paper: „PLANNING AND MANAGING THE IMPLEMENTATION OF THE SIX SIGMA METHOD IN PHARMACEUTICAL INDUSTRY”.

    M.Sc.

    The University of Zagreb, Faculty of Organisation and Informatics

    „Business Systems Management course Corporate management.

    Master of Science /M.Sc/.

    1995 finished graduate science studies at the University of Zagreb, Faculty of Chemical Engineering and Technology, "Chemical Engineering and Technology, course Chemical Engineering" and graduated with the topic "PREPARATION BIOCATALYSTS-ALCOHOL-DEHYDROGENASE".

    B. Sc.

    The University of Zagreb, Faculty of Chemical Engineering and Technology,

    "Chemical Engineering and Technology, course Chemical Engineering".

    Bachelor of Science Chemical Engineering and Technology /B.Sc./

     

     

    2013-2017

    The head packaging process (production of solid dosage forms /tablets, capsules/).

    Implementation and supervision of GMP standards. Organisation of the packing process responsible for implementation and supervision of GMP standards. Coordination among different departments and sectors, tracking and resolving CAPA using ERP SAP, creating and managing production documentation /EDMS Glory-a/. Monitoring and analysis of the trends in production and packaging processes. Preparation of risk assessment by FMEA and AHP methods in thermoforming processes according to the valid standards /GMP and ICH Q8, Q9 and Q10/. Design and implementation of validation protocols as validation of thermoforming.

    Belupo d.d., Danica 5, Koprivnica

    2012-2013

    The head of production and packaging process - Antibiotics (solid dosage forms -semi-synthetic antibiotics/pills, capsules/, oral suspensions, powder oral suspensions), Packaging process - Antibiotics /pills, capsules/, oral suspensions, powder oral suspensions).

    Implementation and supervision of GMP standards. Organisation of the packing process responsible for implementation and supervision of GMP standards. Coordination among different departments and sectors, tracking and resolving CAPA using ERP SAP, creating and managing production documentation /EDMS Glory-a/. Monitoring and analysis of the trends in production and packaging processes.

    Belupo d.d., Koprivnička 7, Ludbreg

    2010-2012

    The head of the packaging semi-solid and liquid drugs (creams, ointments, gels and liquids).

    Implementation and supervision of GMP standards, independent organisation of the filling and packaging process meeting weekly and monthly plans. Introduction of new preparations and devices into the packaging process. Coordination among different departments and sectors, dealing with  CAPA and other deficiencies, managing production documentation. Monitoring and analysis of the trends in production and packaging processes.

    Belupo d.d., Danica 5, Koprivnica

    2003-2010

    Manager of the packaging process – Antibiotics (semi-synthetic antibiotics/pills, capsules, blister pills /cephalosporines, , oral suspensions, powder oral suspensions and other solid forms).

    Implementation and supervision of GMP standards, independent organisation of the filling and packaging process meeting weekly and monthly plans. Coordination among different departments and sectors, dealing with  CAPA and other deficiencies, managing production documentation. Process and equipment validation.

    Belupo d.d., Koprivnička 7, Ludbreg

    2000-2003

    Production manager – Antibiotics (the production of solid preparations, semi-synthetic antibiotics, cephalosporines, oral suspensions, transfer of the existing drugs forms into a new factory).

    Implementation and supervision of GMP standards, independent organisation of dry and wet granulation process, pill production, encapsulation and filling in primary glass containers meeting weekly and monthly plans. Coordination among different departments and sectors, dealing with CAPA and other deficiencies, managing production documentation. Validation of the cleaning process and the equipment.

    Belupo d.d., Koprivnička 7, Ludbreg

    1996-2000

    Technologist in the aseptic production of ampoules.

    Implementation and supervision of GMP standards, monitoring of the process of solution filling into primary glass containers. Monitoring of the production meeting weekly and monthly plans, coordination among different departments and sectors, dealing with CAPA and other deficiencies, managing production documentation. Validation of the cleaning process, equipment and devices.

    Belupo d.d., Koprivnička 7, Ludbreg

     

     

     

Personality

Self Assessment :
AdaptabilityAnalytical thinkingApproachabilityAttention to detailAuthenticityCollaborationCommunicativeCoordinationCreative thinkingFlexibilityInnovative thinkingOptimismOrganizationProactivityProblem solvingStrategic thinking

Knowledge

Self Assessment :
R&DAnalytical Method ValidationAseptic ProcessingAuditingBudgetingBusiness PlanningCAPAcGMPChange ControlChange ManagementChemical EngineeringCleaning ValidationCleanroomCross-functional team leadershipCurrent Good Manufacturing Practice (CGMP)Data AnalysisDesign for Manufacturing (DFM)Design of Experiments (DOE) Good Distribution Practice (GDP)Good Manufacturing Practice (GMP)ICH guidelinesKnowledge of the drug development processLean ManufacturingMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordOutlookPackagingPharmaceutical IndustryPharmaceutical ManufacturingPowerPointProcess EngineeringProcess improvementQA complianceQualificationQuality AuditingRisk AssessmentRisk ManagementRoot Cause Analysis (RCA)SAPSix SigmaSoftware DocumentationStandard Operating Procedure (SOP)Sterile drug productsSterilizationTeam LeadershipTeamworkValidation

Skills and Expertise

Self Assessment :
105|113|905|906|847|2050|2088|646|2054|690

Education

  • Master of Science /M.Sc/. in „Business Systems Management course Corporate management”. from The University of Zagreb, Faculty of Organisation and Informatics in 2011
  • Bachelor of Science Chemical Engineering and Technology /B.Sc./ in "Chemical Engineering and Technology, course Chemical Engineering". from University of Zagreb, Faculty of Chemical Engineering and Technology, in 1989

Training and Certification

  • Statistical process control in 2007 Training
  • Basic statistical methods in 2007 Training
  • Manufacturer of blister foil for solid oral forms (pills and capsules) in 2007 Training
  • Current status and future trends of GMP in Europe in 1997 Training
  • Effective Management of Deviations and Corrective Actions in 2016 Certification
  • Independent GMP auditor in 2011 Certification
  • Good documentation practice in 2007 Certification
  • Pharmaceutical Good Manufacturing Practice (GMP) in 2003 Certification
  • GMP implementation in the glass ampoules production in 1999 Certification
  • European GMP conference the view of European Inspectors /GMP premises/ in 1998 Certification
  • Microbiological Control of Pharmaceutical Waters in 1997 Certification
  • ISPE-European Education Programme in 1996 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Croatian
Professional Proficiency
English
Full Proficiency
Serbian
Professional Proficiency
SLOVENIAN
Full Proficiency
Bosnian
Professional Proficiency
Macedonian
Native

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    Industrial Pharmacist Managing Director Pharmacovigilance Assistant Product Manager Production Supervisor QA Consultant QA Officer Quality Assurance (QA) Manager
  • Locations I am interested in:
    Austria Belgium Denmark Germania Ireland Nederland Norway Slovenia Sweden Switzerland UK
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Varaždin, Croatia

Others

Driving License
  • Yes