Luis Esteban Castillo Palacios
Coordinador técnico at TQfarma- Claim this Profile
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Bio
Credentials
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FORMACIÓN DE AUDITORES INTERNOS EN SISTEMAS DE GESTIÓN INTEGRAL. NTC ISO 9001 :2015, NTC ISO 14001 :2015 Y OHSAS 18001 :2007
ICONTEC InternationalAug, 2017- Nov, 2024
Experience
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TQfarma
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Colombia
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Coordinador técnico
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Jul 2022 - Present
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TQ Confiable - Tecnoquímicas
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Colombia
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Pharmaceutical Manufacturing
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700 & Above Employee
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Laboratory Leader
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Sep 2021 - Jul 2022
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Chemical of Laboratory Senior - Validation of Analytical Methods
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Feb 2018 - Oct 2021
Working with, developing and validating analytical methods, including UHPLC, HPLC, GC, liquid chromatography with different detectors PDA, UV, MS, RI, LSC and combinations, gas chromatography (GC) FID and sample preparation.Risk assessment for life cycle management implementation of validated methods and trasnfer of method.Interpreting results and data and reporting on same.Ensuring the highest standards of quality assurance for GLP.Supporting Quality Control perform chemical analysis to ensure product acceptability. Ensure that final products meet required standards before release by analyzing them using instrumental and chemical techniques according to the specifications. Analyze in-process samples using a variety of assays and procedures, taking appropriate action if the result is out of the specification. Maintaining chemistry lab in good orderDeveloping, executing, implementing, and managing, project for processing and automated reporting of results through Empower 3 FR3 and FR4.Developing, executing, implementing, and managing, project for processing and automated reports Analytical Methods Validation through Empower 3 Enterprise Network FR3 and FR4 in the MVM Module Method Validation Manager.Perform transfer, Standardization, Verification and Validation techniques for analysis by HPLC, UPLC, FTA, the parameters established in the pharmacopoeial standards USP and BP force for evaluation, uniformity and dissolution of active pharmaceutical ingredients, placebos, related compounds, organic impurities following parameters established in the Q2B Validation of Analytical Procedures. Performing analysis Related Compounds, Assessment and dissolution of active ingredients and applicability of the various updates pharmacopoeial products and company processes for quality improvement techniques.Provide training to new members to the working groups and introduce them to the various processes of quality control, stabilities and validations. Show less
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Genfar una Empresa Sanofi
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Genfar a Sanofi Company
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Coordinator of Validations Analytical Methods
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Aug 2017 - Feb 2018
Coordinate area activities validations analytical methods. Conduct KPI's in area validations of analytical methods Conduct comprehensive research, through designing and planning research projects, experimental design and analysis, monitoring and ensuring progress of method validation development, evaluating and delivering accurate scientific data and high quality chromatographic consumable products. LAYERS management concerning internal audits and / or deviations related to analytical techniques or validations of them. Analytical direct transfers between the area of validations of analytical methods Quality control areas and stabilities. Make requests inputs for successful realization of validations of analytical methods. Perform support, guidance and supervision of analysts validations analytical methods in the development and implementation of analytical methods validations. Review and approve protocols and reports validations of analytical methods and to report to the boss. Review and approve reports protocols and analytical methods transfers between Validations area, stabilities and Quality Control. Update the annual validation plan of analytical methods. Keeping the SOP, formats and validations of analytical methods. Set next to the head of stabilities and Regulatory Affairs preservatives some specifications for products that contain them. Show less
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Genfar
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Colombia
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Coordinador de Validaciones de Tecnicas Analíticas
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Aug 2017 - Feb 2018
Coordinar las actividades del área de Validaciones de métodos analíticos.
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Coordinator of Validations of Analytical Techniques
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Aug 2017 - Feb 2018
Coordinate area activities validations analytical methods.Conduct KPI's area validations of analytical methodsCAPAS management concerning internal audits and / or deviations related to analytical techniques or validations of them.Analytical direct transfers between the area of validations of analytical methods, Quality control and stabilities areas.Make requests inputs for successful realization of validations of analytical methods.Perform support, guidance and supervision of analyst of validations of analytical methods in the development and implementation of analytical methods validations.Review and approve protocols and reports validations of analytical methods and to report to the boss.Review and approve reports protocols and analytical methods transfers between Validation area and stabilities and Quality Control areas.Update the annual plan validations of analytical methods.Keeping the SOP formats and validations of analytical methods.Set next to the head of Stabilities and Validations and head of Regulatory Affairs the preservatives specifications for products that contain them. Show less
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International park of creativity
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Colombia
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Chemical Assistant Technical Scientific
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Mar 2009 - Jul 2011
Research of phytochemical composition, bioassay tests and resistance of mircoorganisms was investigated to different types of plants, seaweed and soils using HPLC techniques, UPLC, UV-Visibe, antibiograms, rust - reduction of rezarsurin by planting in dish of 36 wells and qualitative analysis of plants; soil research and substances present using techniques of qualitative analysis and analytical techniques and atomic absorption for determination of metals present, preliminary detection of oil and its major components in soil without prior excavation. Analysis of compound fertilizers from the soil, using techniques of ICONTEC NTC-ISO11464, NTC5402 and NTC 5167. Study of genetic composition of organisms present in Cocoa and Fique using DNA techniques, quantification in agarose gels, PCR for replication of the genetic expression. Desulphurisation or removal of sulfur from crude oil using natural compounds. Development and standardization of a biotechnological process for Casa Luker that allows you to increase the production of polyphenols of high importance in cocoa and peanut without causing genetic modification of the final product of the cocoa using microorganisms related to cocoa previously modified by means of Synthetic Biology. Well same development, standardisation and validation of an extraction technique, identification and quantification of phenolic compounds in cocoa, using instrumental techniques in UV-visible spectrophotometry and HPLC and coloring techniques and NAFTA. Phytochemical study, extraction and quantification of carotenoid compounds of lulo and corns of lulo. Research and development of a methodology for production and extraction of carbohydrates and phenolic products from husks and residues of coffee and cocoa producer system using as treatment with freeze dry explosion and treatment with Aspergillus. Show less
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Education
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Universidad del Quindío
Quimico, Investigación, Desarrollo y análisis de productos farmacéuticos -
ICONTEC
Auditor Interno, Calidad, Auditoría, Sistemas de Gestión, HSEQ, ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007 -
ICONTEC
Auditor Interno HSEQ, Calidad -
Universidad Europea del Atlántico
Máster en Organización de Empresas y Proyectos Industriales, Ingeniería, Calidad -
Universidad Internacional Iberoamericana de México (UNINI México)
Maestría en Ingeniería Industrial, Ingeniería Industria, Calidad -
Universidad Internacional Iberoamericana de México (UNINI México)
Maestria en Ingeniería Industrial, Administración y gestión de empresas, general -
Universidad Internacional Iberoamericana de México (UNINI México)
Maestria en Ingeniería Industrial, Administración y gestión de empresas, general, Calidad