Milan Kalinic
COMPANY: Alexion ROLE: Validation Lead

Milan Kalinic is Pharmaceutical professional specializing in Sterile Fill Finish and Solid Dosage manufacturing environment with more than 13 years of experience. Currently works as a Validation Lead at Alexion Pharmaceuticals. Previous position includes Validation Specialist at Hemofarm (Member of STADA Arzneimittel Group). Milan was responsible for Leading of cross functional  CQV Teams and manufacturing equipment projects delivery within the Hemofarm Group such as: Start-up of the Syringes & Cartridges Manufacturing Site, Start-up of the Ampoules Manufacturing Site and Start-up of the Sterile Nasal Spray Manufacturing Site.  Also, he was responsible for leading a Packaging Lines CQV team for start-up of Packaging Center for Solid Dosages Forms.  Milan is manufacturing specialist for Filling Lines (CIP/SIP and Isolators), Compounding Systems, Autoclaves, Freeze Dryers, HVAC, Water Systems and Systems for Pharmaceutical Gases. He was selected by the “Amphenol Advanced Sensors” as one of the worldwide Kaye Validator SME’s to support the development of the new generation of the Validator which was recently successfully released.


As a Validation Lead in Alexion Pharmaceuticals Milan is responsible for new drug product introduction from validation perspective and managing and providing oversight of validation equipment and systems at Manufacturing Site. Milan also developed a robust validation program in line with the best industry practice and current regulatory expectations to ensure that all GMP manufacturing processes are maintained in validated state. He studied Mechanical Engineering at College of Engineering and Professional Studies of Belgrade University.


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