Fatima Saravia
CHEMISTRY TECHNICAL SPECIALIST at JMC NC INC- Claim this Profile
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English Full professional proficiency
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Spanish Native or bilingual proficiency
Topline Score
Bio
Credentials
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“Limulus Test - Bacterial Endotoxin Quantification"
SAFYBINov, 2018- Nov, 2024 -
Training Certificate HACCP Expert
DQS Inc.Apr, 2017- Nov, 2024 -
Internal Audits Focused in The Improvement of the Organization
Diplomado Gestión Calidad by ICONTEC.Apr, 2016- Nov, 2024 -
Quality Management Systems Fundamentals ISO 9001: 2015
Diplomado Gestión Calidad by ICONTEC.Apr, 2016- Nov, 2024 -
Certified Pharmaceutical
JVPQFJan, 2012- Nov, 2024
Experience
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JMC NC INC
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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CHEMISTRY TECHNICAL SPECIALIST
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Jan 2020 - Present
-Quote materials, equipment and primary/secondary standards for pharmaceutical industry (USP, Chromadex, Agilent, etc) adjusting to estimation, budget and specifications for customers. -Respond, assist and address questions and doubts about materiales/ standards purchased by clients for final appropiate use. -Revise compliance of legal regulations for export: DEA, EAR, TSCA, EPA and others -Quote materials, equipment and primary/secondary standards for pharmaceutical industry (USP, Chromadex, Agilent, etc) adjusting to estimation, budget and specifications for customers. -Respond, assist and address questions and doubts about materiales/ standards purchased by clients for final appropiate use. -Revise compliance of legal regulations for export: DEA, EAR, TSCA, EPA and others
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Laboratorios Ferson
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1 - 100 Employee
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QUALITY INTEGRATED MANAGEMENT SYSTEMS SUPERVISOR
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Jul 2017 - May 2019
-Audit good manufacturing practices for pharmaceutical industry and implementation of Quality Management System based on ISO, CGMP-FDA Act 21 CFR Guidelines and Good Laboratory Practices.-Lead CAPA (corrective and preventive action) and improvement activities -Lead investigation for laboratory and manufacturing deviations (IA, OOS, AR) -Actualization and creating SOPs accordance with QC and manufacturing process. -Revise information generated in Laboratory Information Management System (LIMS)-Review phases included in batch production record and documentation/ register involved such: lot, packaging/labeled, distribution, identification for equipment/processing lines, sanitization records, manufacturing, QC, master manufacturing process, approved or rejected activities, etc. -Programing and following for equipment/instrument program calibration -Coordinate manufacturing operating procedures compliance -Coordinate main phases of validation process in equipment and process ( Design qualification, Installation qualification, Operational Qualification, Performance Qualification and Validation) based on USP and FDA standars for sterile and nonsterile final products.
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LivSmart
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Food & Beverages
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100 - 200 Employee
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AUDIT COORDINATOR
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Jan 2015 - Jul 2017
-Audit Good Manufacturing Practices and HACCP System for food industry.-Monitoring compliance in food production starting from weighing, formulation, packaging, storage, dispatch, transfer, and others critical process activities, etc. -Management of Production Indicators for food industry and monitoring of integrated systems for ISO 22000 (food industry), 14000 (environmental management), 45001 (occupational health and safety), and ISO 9001: 2015. -Audit Good Manufacturing Practices and HACCP System for food industry.-Monitoring compliance in food production starting from weighing, formulation, packaging, storage, dispatch, transfer, and others critical process activities, etc. -Management of Production Indicators for food industry and monitoring of integrated systems for ISO 22000 (food industry), 14000 (environmental management), 45001 (occupational health and safety), and ISO 9001: 2015.
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PAILL Laboratorios
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El Salvador
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Pharmaceutical Manufacturing
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100 - 200 Employee
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MICROBIOLOGY SUPERVISOR
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Jun 2013 - Dec 2014
-Management of internal processes related to Quality Assurance in the department of microbiology analysis: preparation of culture media, approval of sensitivity tests of culture media, maintenance of strains, microbiological examination of nonsterile products, sterility test, microbial Identification, testing of microbial antibiotics potency techniques, bacterial endotoxin test (LAL), reading and determining interpretation of microbiological results, etc. -Management of purchasing / inventories of lab supply's and consumables- Issuing of certificates of analysis.-Apply microbiological techniques to enviromental and surface control in clean rooms, taking samples throught various environmental monitoring equipment (viable and non-viable), antimicrobial effectiveness test and validation of sterilization process and documentation for SOP’s.
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QUALITY CONTROL ANALIST
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Apr 2011 - Jun 2013
Physicochemical and microbiological analysis of raw material, final product in primary packaging, and medical devices with analysis techniques based on USP requirements and pharmaceutical stability test assay. Strong knowledge about Shimadzu and Perkin Elmer HPLC, spectroscopy UV- VIS, viscometer, pHmeter and others QC analysis equipment.
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Education
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2014 - 2016
Universidad Rey Juan Carlos
Master's degree, Master in Quality Integrated Management System (Enviroment, QC and Health and Safety) -
2012 - 2014
Universidad de El Salvador
Master's degree, Master in Business Consulting -
2006 - 2012
Universidad de El Salvador
Bachelor's degree, Chemist and Pharmacist
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