•Milja Nesic– General Manager
Expert team:
• Miroslava Dragojevic, Ph.D. – Business development
Director
35 Years experience in Pharmaceutical Industry, 15 years management in R&D, Manufacturing, Quality, Investments and Technology Transfer.
Author of over 30 technologies for solid dosage forms, author of over 10 business studies, leader of numerous projects.
• Dobrivoje Dzipkovic, B.Sc. Mechanical Engineer – Capital Investments
Director
25 years of experience in engineering, 10 years management in pharmaceutical capital investments
Author of over 30 project designs, management of 9 new plant building and 11 plants reconstruction.
•Gerry Prout, MB.BS. – Quality Operations Director
45 Years Quality positions in pharmaceuticals, brewing industry and medical devices. Member of Royal Society of Medicine.
• Jim Chissell, MSc. Chemistry – Manufacturing & Regulatory Expert
30 Years experience in multi national and intermediate sized pharmaceutical
companies, involved with the setting and implementation of medicinal quality
standards for a very comprehensive range of medicinal product forms including
sterile products.
Member of British Institute of Regulatory Affairs and British Pharmacopoeia
Committee. Qualified Person as defined by Directive 75/319/EEC.
• John Sharp, B.Sc. Chemistry – GMP & Training Expert
20 years experience in pharmacy (chemical analysis, QC/QA, production),
15 years member of UK Medicines Inspectorate. Since 1987 he has run his
own consultancy business.
Author of over 70 published papers, books booklets and manuals (including
three entire modules in the Manchester University Advanced Pharmaceutical
Training series and four modules for the ABPI NVQ Operator Training series).
Member of RSC’s panel of assessors for Qualified Persons, Royal Pharmaceutical
Society, Institute of Biology and Parenteral Society. Member of the Editorial
Board of the European Journal of Parenteral Sciences.
• Verica Ivkovic, B.Sc. Pharmacy – Quality Assurance Director
20 years experience in pharmacy, 12 years management in Manufacturing
and Quality.
Licensed auditor according to EU standards. Author of numerous GMP and
validation documents prepared according to FDA and EU regulation.
• Mike Zaccheo, B.Sc. Microbiology – Microbiology & Sterile production
Expert
22 years experience in pharmacy, mainly in microbiological laboratories,
sterile production and sterilizing process and autoclaves validation.
Last 10 years director and technical consultant to pharmaceutical Industry,
specializing in manufacturing and sterilizing process development and
validation, microbiological QA, regulatory compliance, documentation and
training.
Associate of the Institute of Biomedical Sciences, Management Committee
Member of the Parenteral Society, Member of the Pharmaceutical Microbiology
Interest Group.
• Viska Miceska, B.Sc. Pharmacy – Validation Director
16 years experience in pharmaceutical industry, 5 years management in
Manufacturing and Process Development.
Licensed auditor according to EU standards. Author of numerous validation
protocols & reports and GMP documentation prepared according to the
FDA and EU regulatory requirements
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