Filip Grujevski

Qualification Engineer at ALKALOID AD

Expert status:

12 month points:

Total points:

Beginner
124
124
Awards earned
0
Gold
0
Silver
0
Bronze
menu Summary

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

ALKALOID AD

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 spaces, all types of laboratory equipment and laboratory environment systems (HVAC).
Specifying and evaluating laboratory equipment and systems.
Project commissioning.
Regulatory compliance (GxP, CFR, USP, BP,EP, ISPE...)
Certified Service Engineer for Hitachi VWR, Waters, Shimadzu and Agilent systems (HPLC,UPLC,Dissolution systems,Spectrophotometers).
Many trainings and seminars about compliance, qualification, validation, maintenance in analytical laboratories.
Extensive experience with audits, compliance, commissioning, standards in pharmaceutical quality control.