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Style & Ideals

=Management team. Implementation (vision + leadership + capital (human, $ $ $)) 

Team: Let one plus one are equals three ... great minds generate great ideas; avoid pitfalls by learning from the best.

Knowledge: People with a broad multidisciplinary knowledge have great opportunities to create a superior strategy, plans and innovation.

Strategy: Develop a deep understanding of quality systems, qualified suppliers, train staff and monitor staff performance - improvements based on feedback from internal and external audits.

Execution: Time of occurrence in the market can sometimes go in our favor, the other 100% success make swivel, highly efficient and employees focused on the job at all levels.

Desire: Passion to win, no matter what the obstacles.

Briefly

MSc in chemistry with many years (over 20 years) professional interests in the implementation of quality systems, technology transfer (transfer quality procedures, methods and equipment), qualification of suppliers (selection and qualification of suppliers of raw materials), development of product quality (optimization of efficient production, development and validation analytical methods), statistical process control (trend analysis) and scientific experience in the field of free radical chemistry, kinetics of free-radical reactions, drug interactions with trace elements in systems of various levels of complexity.
Author and co-author of several scientific papers in the world's most famous magazines. Author Module 2 Quality Overall Summary for several drug company Habit Pharm. Author Site Master File for the same company.

Work History

2015Present

Consultant - laboratory specialist

Lemis

Consultant activities for forming and startup laboratories.

Project: Modernization of University Montenegro

Project in Armenia: Development Laboratory for Pharmaceutical and Development Laboratory for Food safety unit

Project: Georgian Research Institute for Energy and Hydrotechnicks in Tbilisi Georgia

20142015

The person responsible for quality control of medical devices

Ivancic i sinovi
  • Responsible for quality control of medical devices
  • Risk management and quality evaluation of measurement uncertainty
  • Responsible for the implementation of quality systems laboratory (qualifications, training, validation)
20102014

Head of Quality Control

Ivancic i sinovi
  • Responsibility for the physical and chemical and microbiological testing of raw materials, semi-finished products and control conditions and environmental protection in production
  • Stability studies / write protocol and stability evaluation results in accordance with the directives of ICH
  • Experience with local GMP inspections
  • Responsible for the implementation of quality systems laboratory (qualifications, training, validation)
  • Responsible for the purchase of analytical equipment according to customer requirements (URS)
  • Audit manufacturers under contract and qualifying suppliers
  • Responsible for the development and establishment of quality control laboratories in the new factory
  • The leader or member of several projects: the implementation of GMP directives in production and quality control of medicines, ISO 17025, ISO 14000, HACCP
  • Member of the team for the implementation of Microsoft Dynamics AX system
Oct 20082010

Quality Director

Habit Pharm

In charge of organizing the work of quality assurance, quality control and Development and validation.

  • Preparation of annual reports;
  • Implementation, maintenance, monitoring and improving capacity development in compliance with GMP, ISO 9001: 2008;
  • Document management system at all levels;
  • Development and implementation of internal quality audits; verification of the effectiveness and implementation of pharmaceutical quality assurance system;
  • Management control procedures changes;
  • Approval of validation and qualification documents;
  • Research and management of nonconformities and results outside the specifications (if any);
  • Managing inconsistencies and withdrawal (if any);
  • Defining and implementing corrective / preventive measures;
  • Qualification, verification and approval of suppliers;
  • The implementation of the training program and periodic evaluation of training;
  • Participation in product development and approval of the Agreement on the quality in case of contract manufacturing and analysis;
  • Participation in external GMP inspection / quality control.
Jun 2007Oct 2008

Head of Development and validation

Habit Pharm

Responsible for the development of validation master plan, the planning and monitoring of validation activities with the development of supporting documentation quality assurance system.

Jan 2007Jun 2007

professor of Chemistry

School of Arts

Teaching chemistry at teaching plans and programs.

Jan 2007Jun 2007

professor of Chemistry

O.Š. Nada Matić

Teaching chemistry at teaching plans and programs.

20052007

Quality director

Jemix

The development and improvement of the quality in the production of closures for pharmaceutical industry (push on cap, aluminum closures). Consideration of all aspects of pharmaceutical packaging, from the technical (compatibility and stability, influence the quality of the packaging process) to regulators.

Chemicals food. Chemical (lipid oxidation), physical (dehydration) and microbiological food protection. Development of methods for the synthesis and opeme additives. Formulation of complex mixtures of additives. The development of analytical methods for the qualitative and quantitative determination of additives.

19972005

Director of Development

Genezis

The development of new methods for the synthesis of pure chemicals.

19931997

Research Associate

Institute Vinča

Reaction mechanisms of biologically active compounds with bioelement in heterogeneous systems. The kinetics and mechanism of the reaction protolytes biologically active functional groups with metals in micellar systems (techniques liquid chromatography (HPLC), UV and IR spectroscopy, GS MS, stopped flow). Determination protolytes constants antibiotics. The interaction of antibiotics with other drugs in parallel during therapy, as well as essential elements in serum (Fe, Cu, Pd, Mg).

Free-radical reactions. The mechanism of oxidation kinetics and mechanism of action of antioxidants in natural and artificial systems of various levels of complexity. Techniques impulse, g-radiolysis and flash photolysis to generate and study of free radical reactions. Isolation and characterization of natural antioxidants from plants (flavones and flavonoids). Organic synthesis of new antioxidants.

Immuno Chemistry and immune response. Isolation and characterization of human immunoglobulin. Immunoelectrophoresis techniques and radio immuno assay.

19901993

junior researcher

Institute Vinča

Free-radical reactions. The mechanism of oxidation kinetics and mechanism of action of antioxidants in natural and artificial systems of various levels of complexity. Techniques impulse, g-radiolysis and flash photolysis to generate and study of free radical reactions. Isolation and characterization of natural antioxidants from plants (flavones and flavonoids). Organic synthesis of new antioxidants.

Education

Oct 1987Oct 1992

Master of Chemistry, MSci

Faculty of Chemistry

Master Thesis: Study of antioxidant properties polysupstitueted phenol and derivatives of pyrrole

19821987

graduate chemist, BSci

Hemijski fakultet

Graduation thesis: Isolation and characterization of human immunoglobulin M

Portfolio

Non professional interest

Blogging (http://griffonvulturepharma.blogspot.com/), literature, history, sport (chess).

Published articles

  1. S.Večerkov Vukmirović , M.Tošić, , "Approach to through risk analysis - a tool for the effective qualification of suppliers, "Total Quality Management & Excellence '', Vol. 36, No. 1 - 2, 2008, YUSQ ICQ 2008
  2. V.M. Vasić, M.S. Tošić, T. Jovanović, Lj.S. Vujisić, J.M. Nedeljković, “Kinetics of chelate formation between PdII and S-carboxymethyl-L-cysteine”, Polyhedron, 17, 399-403 (1998).
  3. M.S. Tošić, V.M. Vasić, J.M. Nedeljković, Lj.A. Ilić, “Influence of sodium dodecyl sulfate micelles on the kinetics of complex formation between Pd(H2O)42+ and glutathione”, Polyhedron, 16, 1157-1160 (1997).
  4. V.M., Vasić, M.S., Tošić, J. M., Nedeljković, “ Influence of sodium dodecyl sulfate micelles on the kinetics of complex formation betweenPd(H2O)42+ and S-carboxymethyl- L-cysteine”J. Phys. Org. Chem. 9, 398-402 (1996).
  5. V.M. Vasić, M.S..Tošić,J.M. Nedeljković, Lj.Vujsić, “ Kinetics of Chelate Formation between Pd (H2O)42+ and S-carboxymethy-L-cysteine”, 5TH Symposium on Kinetics and Analitical Chemistry KAC95, 25-29 september, 1995, Moscow, Russian.
  6. V.M.Vasić,M.S.Tošić,J. M. Nedeljković,“ Influence of Sodium Dodecyl Sulfate Micelles on the Kinetics of Complex Formation BetweenPd(H2O)42+ and S-carboxymethyl- L - cysteine”5TH European Symposium on Organic Reactivity, Santiago de Compostela, Spain, July 16 - 21, Book of Abstracts, page 140, 1995.
  7. S.V.Jovanović, S. Steenken, M. Tošić, B.Marjanović, M.G.Simić, “ Flavonoids as Antioxidants”,J. Am. Chem. Soc., 116, 4846 - 4851 (1994).
  8. S.V.Jovanović,M.Tošić,B. Marjanović, “To study the antioxidant capacity of the ginkgo extract EGb 761 "XXXV Meeting of the Serbian Chemical Society, Belgrade, Yugoslavia, January 18 - 20, abstract book, page 125, in 1993.
  9. S.V.Jovanović,M.Tošić, B. Marjanović, M. Gologović - Kolb,S. Arsenijević,“Dimetoksifenol kao antioksidans za mineralna ulja”, GALAX 93, Kopaonik, Jugoslavija, Maj 26 - 29, Zbornik radova, strana 67, 1993.
  10. M. Tošić, S. Milojković, M.G. Simić, S.V. Jovanović,“ Dimerizacija guanilovih radikala”, I Savetovanje Društva fizikohemičara Srbije, Beograd, Jugoslavija, Oktobar 7 - 9, Knjiga apstrakata, strana 182, 1992.
  11. M. Tošić,S.V .Jovanović,“ Sinteza i antioksidativne osobine 4-vinil-2,6-dimetoksifenola”, XXXIV Savetovanje srpskog hemijskog društva, Beograd, Jugoslavija, Januar 16 - 17, Knjiga apstrakata, strana 65, 1992.
  12. S.V. Jovanović,M.Tošić, M.G. Simić,“Use of the Hammett Correlation for Calculation of One-Electron Redox Potentials of Antioxidants with σ+ ”,J. Phys. Chem., 95, 10824-10827 (1991).
  13. S.V. Jovanović,M. Tošić, M.G. Simić, "Reakcije cikloheksilperoksi radikala sa derivatima fenola", XXXI Savetovanje srpskog hemijskog društva, Beograd, Jugoslavija, Januar 18 - 20, Knjiga apstrakata, strana 66, 1989.

Portfolio

Quality control

Quality Management

SRPS ENISO 17025

SRPS ISO 9001

SRPS ISO 14000

Certifications

20142014

University of  Wisconsin Madison

Process Monitoring & Metrics to comply with FDASIA 705/706

20132013

University of Wisconsin Madison

Protecting Your Intellectual Property

Apr 2012Apr 2012

European Compliance Academy

GMP meets GLP - a practical approach
20122012

European Compliance Agency

GMP meets GLP - a practical aproach

20122012

JUSK

Međunarodna konvencija o kvalitetu "Kvalitetom ka evropskim i svetskim integracijama", ICQ 2012

Apr 2011Apr 2011

LGC

Pharma seminar
20112011

LGC

Pharma seminar, Beograd 2011

Jun 2009Jul 2009

United Association of Serbia for Quality

National Certificate for Quality Improvement
Mar 2009Mar 2009

AQA

Interna provera sistema menadžmenta kvalitetom
Nov 2008Nov 2008

ALIMS

Ispitivanje biološke raspoloživosti i biološke ekvivalentnosti lekova - regulatorni i praktični aspekti
May 2008May 2008

JUSK

Međunarodna konvencija o kvalitetu "Kvalitetom ka evropskim i svetskim integracijama", ICQ 2012

Sep 2007Nov 2007

IIS- Istraživački i tehnološki centar

Interne provere prema ISO 9001:2000 i ISO 9011:2002

broj sertifikata: 08-143/2007

Oct 2007Nov 2007

ALIMS

The impurities in pharmaceutical products

Sep 2007Oct 2007

Interne provere prema ISO 14001:2004 i ISO 9011:2002

broj sertifikata: 08E-062/2007

Sep 2007Sep 2007

Farmaceutsko društvo Srbije

In vitro ispitivanje brzine rastvaranja: uloga u biofarmaceutskoj karakterizaciji preparata

Seminari


- Sales Meeting at Meteka company, September 2015, Judenburg, Austria

- Trouble-Free HPLC Analysis of Creams and Lotions: Beautiful separations of beauty products, LGC, Live webcast

- Simplifying Carbohydrate Testing in Food and Beverages to Meet Food Quality and Labeing Requirements Using Ion Chromatography and Pulsed Amperometric Detection,  April 03, 2015 ,  Thermo Sciientific

- Water Activity: Implications for Implementing FSMA Rules
Presenters:Michelle J Richardson, Senior Food Scientist, U S Army, Tejas Bhatt, Program Director,Global Food Traceability Center, Institute of Food Technologists
May 21, 2014

-  „DRcaps® Capsules - The preferred choice for delivery of probiotics and acid sensitive ingredients“, Capsulgel, 2013.

- Powder Stability with Water Activity, 28.05.2013.

- Reference materials and standards: Certificates of analysis 23.05.2013.

-  Primary and secondary reference standards in pharmaceutical QC 25.04.2013

-  A Quality by Design Approach for Stability Testing, 26.03.2013.

-  The specifics of pharmacopoeial reference standards, 21.03.2013.

-  Beyond the Basics - Water Activity , February 22, 2013 by Brady Carter

Text Section

Portfolio

Skills

Origin
MS Office

Word, Excel, Power Point, One Note

Text Section