Técnico laboratório
Car*** ***** (XX anos)
Quality Control Analyst em Hovione FarmaCiência, Portugal
Instituto Superior de Engenharia de Lisboa (ISEL)
Vila Franca de Xira,
Lisboa
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Experiência
Quality Control Analyst
Hovione FarmaCiência, Portugal
nov 2015
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Atualmente
• As a Quality Control Analyst in Stability Group, I perform chemical analysis to different products. • Experience in cGMP environment with interpretation of analytical results according current specification. • My independence work in the lab required excellent troubleshooting skills and creative problem-solving skills while maintaining the highest levels of compliance. • Capable to good communication with the team to ensure all tasks are completed with the deadlines stablish. • Responsible for monthly calibration of UV-Visible spectroscopy equipment, Coulometric equipment and monthly calibration of the analytical scales. • Perform analysis of description, colourless, completeness of solution and solubilities. • Perform analysis identification by Infra-Red Spectroscopy (Omnic 9.6 Sotware). • Perform particle size distribution analysis (Mastersizer 2000/3000 and Coulter software). • Expert in water content analysis such as Loss and dry, KF volumetric, Coulometric and KF Oven (Tiamo Software). • Capable to perform assay analysis by Titrations, Potenciometry and UV-Visible (Cary Win UV Software). • Capable in LIMS, CAPA, Xnet and Microsoft Office. From Oct.2017 to Apr.2018 and from Nov.2018 to May.2019 : • Responsible for verification of analytical equipments calibrations. • Responsible for harmonisation of KF’s methods (Tiamo software) in the work area and implementation of a working instruction to create/revise methods for the entire company. • Review results generated by analysts for compliance with requirements. • Reviewed documentation for archiving and did all required to keep the lab in a constant state of audit readiness. • Responsible for update the version of the sub-tests in LIMS according new protocols. • Continuous interaction with other departments, kept colleagues informed of current issues and developments as appropriate.
Quality Control Analyst
Atral, Indústria Farmacêutica, Portugal
out 2012
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set 2015
• As a Quality Control Analyst in Raw Materials Group, I performed analysis to raw materials, packing material, and Purified Water. • Experience in cGMP environment with interpretation of analytical results according current grade specification. • Perform physical and chemical tests according Ph.Eur, USP and JP grade. • Perform analysis of description, colourless, completeness of solution and solubilities. • Perform physicochemical tests such as Spectrometry with UV/Vis absorption, IV and NIR (OPUS Software). • Perform TLC, Bulk density, pH,Sulfuric ash, Heavy metals, Titrations, Viscosity, Potenciometry and Conductivity tests. • Perform water content analysis by Loss and dry technique and KF volumetric (Methrom Software). • Training in Liquid and Gas Chromatography (Agilent, Open Lab software) • Experience in the operation and maintenance of HPLC (Agilent) equipment. Perform Assay and Related impurities by HPLC analysis.
Inter/Trainee in Quality Control
Atral, Indústria Farmacêutica, Portugal
mar 2012
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jun 2015
• As a Inter in Quality Control I was responsible for Sampling Purified Water, necessary to Water validation; • Perform water chemical analysis such as oxidizable substances, Heavy Metals, Conductivity pH, for the Purified Water validation.
Formação
Chemical and Biological
Instituto Superior de Engenharia de Lisboa (ISEL)
set 2008
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mai 2012
Bachelor degree in Chemical and Biological Engineering
Idiomas
Inglês - A2
Informações Adicionais
Skills
• Quality review of analytical data; • Knowledge of CAPA system, SAP and LIMS; • Excellent knowledge of computer use, especially in Windows environment and good knowledge in the operation of Office package; • Karl-Fischer ( Volumetric, Coulorimetric and Oven); • Tiamo Software; • UV/Vis Spectroscopy and Infra-Red Spectroscopy; • Omnic 9.6 Sotware ; • Cary Win UV Software; • Particle size distribution; • Mastersizer 2000 and Coulter software; • Near Infrared Spectroscopy”-NIR/FTIR; • OPUS software; • HPLC/GC Agilent’s equipment; • Classical chemistry techniques such as volumetric titrations, purifications and recrystallization, TLC (Thin-Layer Chromatography), identifications, among others; • Teamwork ability; • Ease to adapt to new tasks and great independence in work performance; • Versatility being able to perform several complementary tasks and of different nature; • Always willing to improve my knowledge and learn new subjects and techniques; • High sense of organization and responsibility;