Filip Grujevski

Analytical Systems Qualification Responsible at ALKALOID AD

Expert status:

12 month points:

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Interested in Data Centers, Cooling, using sustainable energy sources, working on Energy Efficiency projects, Facility Management, learning, constant improvement, Turbomachinery, Thermotechnics, Thermoenergetics, HVAC, Thermal Engineering, Thermodynamics, Fluid Mechanics, Compressors, Chromatography, Instrumentation, Adobe CS5, AutoCAD, SolidWORKS, Mechanical Desktop, CorelDRAW, MS Office, MATLAB, Catia, NX, Retrofitting, Energy, Energy Efficiency, Pharmaceuticals, Industry, Production, Pharma, Laboratory, Cooling, Process..

work Experience

Qualification Responsible (Preventive Maintenance, Maintenance, Qualification of Analytical Systems)


May 2009 - Present

Analytical Instruments Responsible (working in QC and R&D)

Responsible for Preventive Maintenance, Predictive Maintenance, Qualification, Calibration, Validation of complex analytical instrumentation and systems used in pharmaceutical QC and R&D.
Proficient in writing SOPs, qualification documentation, equipment testing, manuals, maintenance planning and strategies, defining equipment specifications, URS for laboratory premises, URS for all types of laboratory equipment. Specifying and evaluating laboratory equipment and analytical computerized systems.
Participation in Laboratory CDS Software URS, demo and evaluation project. Project commissioning.Extensive knowledge in Pharmaceutical Standards and Guidelines (GxP, CFR, USP, BP,EP, ISPE, ASHRAE, ISO...).
Trained Service Engineer for Hitachi VWR, Waters, Shimadzu, Thermo Scientific and Agilent systems (HPLC,UPLC,Dissolution systems,Spectrophotometers).
Highly trained in compliance, qualification, validation, maintenance in analytical laboratories.Extensive experience with audits, compliance, commissioning, standards in Pharmaceutical Quality Control.
Participation in many projects for example: building new laboratory facilities, new software implementations, implementation and qualification of laboratory systems.
Knowledge of ISO 9001,ISO 14001,ISO 17025,ISO 13485,ISO 50000, OHSAS standards.

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