EXPERT OPPORTUNITIES

Filip Grujevski

Analytical Systems Qualification Responsible at ALKALOID AD

Status:

12 month points:

Total points:

Novice
126
126

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 Responsible (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 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.


Domains of experience:

Macedonian
Solidworks
Matlab
AutoCAD
HVAC
Fluid Mechanics
Thermodynamics
Turbomachinery
Validation
Finite Element Analysis
Project Engineering
Microsoft Office
Air Compressors
Mechanical Engineering
CAD
Thermal Engineering
Energy
CFD
Heat Transfer
AutoCAD Mechanical
Sustainability
Solar Energy
Solid Edge
R&D
Pro Engineer
Unigraphics
Renewable Energy
Medical Devices
Inventor
Engineering
Catia
Quality System
AutoDesk Inventor
PTC Creo
NX Unigraphics
Process Engineering
Project Management
Project Planning
English
Commissioning
Quality Control
Teamwork
Pumps
Instrumentation
Research
Energy Efficiency
Product Development
Management
stars Convetit Experience

08/2017 - 10/2017

Participated on a Discovery Board on

Predictive Maintenance
Predictive Modeling
Chemicals
Data Analysis
Predictive Analytics

Recent Open Board Activity:

No activity yet.