Experience

Anvac

• Argentina
• Biotechnology Research
• 1 - 100 Employee

• Quality System Consultant

  • Mar 2021 - Present

  Somos una empresa enfocada en el mantenimiento, calificación y reparación de sistemas cromatográficos para laboratorios. Somos una empresa enfocada en el mantenimiento, calificación y reparación de sistemas cromatográficos para laboratorios.



Johnson & Johnson

• Law Practice
• 1 - 100 Employee

• QUALITY SYSTEMS SR. ANALYST

  • Mar 2020 - Mar 2021

  • Monitoring and management for compliance and verification ofthe action plan resulting from the Internal Quality Audits andguarantee that the information corresponding to thismanagement (indicators,reports, etc.) is update and reported.• Selection of Suppliers, Approval of Qualification andGovernance of suppliers of Indirect Materials and Services.• Generate and update quality agreements with direct andindirect service providers when applicable.• Carry out training for new personnel on the following topics:Basic Quality Induction,• Symphony (INV, CAPA, GCC modules if applicable to theposition).• Ensure the deployment of corporate policies and localregulations to the people responsible for the different areas thatare part of the quality system.• Manage the information systems that support the quality systemdocumentation (trū, Symphony, Compliance Wire).• Manage the information systems that support the quality systemdocumentation (trū, Symphony, Compliance Wire).Participate inGlobal / Regional projects that involve the implementation of new versions of the systems and lead implementation activitiesat the local level.• Guarantee the consolidation and timely reporting of thedifferent local and regional indicators. Show less

• PLANT MICROBIOLOGY SPECIALIST

  • Aug 2018 - Mar 2020

  Primary rol: Responsible for following up and providing support in all Non Conformance, Investigations, CAPAs, Global Control Changes, related with aspects of microbiological risk. Ensures that all products meet quality requirements, standard operating procedures, government regulations, and comply with good practices of manufacturing. Participate in quality investigations and / or internal audits to evaluate compliance with the specifications, company procedures and general compliance with regulations. Use statistical analysis to solve problems and solve quality problems. Lead the cleaning and sanitization validations of the plant. Develop strategies and objectives for the implementation of good hygienic practices in all areas of the Plant to ensure that all products comply with the company's microbiological standards. Develop and update Standard Operating Procedures (SOP) with the objective of reducing risk microbiological and contributing to improve the design of equipment, maintenance tasks, processes of manufacturing, cleaning processes and disinfection of equipment. Training the manufacturing personnel on issues related to hygiene, cleanliness, good practices of manufacturing, the risks of microbiological contamination and the sanitary design of equipment. Provide technical expertise to colleagues regarding the interpretation and / or implementation of guides and recommendations on good hygienic practices. Perform audits of good hygienic practices in the productive areas and the laboratory. Carry out investigations of microbiological contaminations in the company's finished products to ensure that the true root cause is identified, documented and corrected. Prepare and submit written and verbal reports that indicate the hygienic state of the installation, including deviations, equipment design, compliance with corporate policy and good practices. Show less

• MICROBIOLOGYST COORDINATOR

  • Apr 2016 - Jul 2018

  Planning of daily tasks: Coordination of the execution ofmicrobiological tests to support the commercial release of finalproducts. Coordination of the execution of environmentalmonitoring according to schedule.• Review and correction of documentation.• Support/lead investigation of aberrant / OOT result investigationsrelated to testing.• Management of laboratory quality system: deviations / CAPA`s /Change Controls.• Develop / prepare and review of microbiological methodsprocedures, Micro Lab procedures.• Reviewing microbiological method transfer/validation protocolsand final reports.• Execute microbiological method transfer / validation.• Review technical information, stability data and assay controls.Perform environmental monitoring as per requirements• Assist instruments and equipment calibration and qualificationactivities in compliance with the annual program.• Develop requirements and support the acquisition of new QCequipment / instruments, test samples, reagents and standards.• Provide support during inspections and internal audits.Responsible for implementing corrective and preventive plans tothe observations made.• Management of indicators.• Provide trainings to new analysts.• Perform general laboratory activities of quality control inaccordance with the procedures of QC Lab, GMP and localregulations. Show less



Laboratorios Phoenix SAICF

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• MICROBIOLOGYST COORDINATOR

  • Dec 2013 - Oct 2015

  Planning daily routine.• Support method transfers with contract labs in all South Coneregion• Review and correct documentation.• Buy and Control of stock of supplies and reagents.• Opening and monitoring of deviations, CAPA`s , ControlsChanges, Results Out of Specification (OOS) and Tendency(OOT) related to the sector.• Periodic review and generation of new SOP`s• Staff in charge: 5

• Analista Sr. microbiologìa

  • Jun 2012 - Nov 2013

   Coordinación y corrección de ensayos de Esterilidades, Controles higiénicos y análisis de aguas. Generación de Certificados de Anàlisis. Control de libros de eventos. Manejo de Controles de cambios del sector.  Redacciòn de Procedimientos operativos e Instructivos de trabajos.  Test de endotoxinas bacterianas LAL (Limulus Amebocyte Lysate) por el método de Gel Clot.  Test de Elisa para la detección de Anticuerpos monoclonales (Belimumab).



Bayer HealthCare

• United States

• MICROBIOLOGYST ANALYST

  • Aug 2011 - Nov 2012

  Microbiological controls: Finished product, raw materials, purified and potable water. • Product and processes validation. • Growth promotion test. • Biochemical tests/typification (Gram,s staining, catalasa, oxidasa, cuagulasa, etc) • Identification with Vitek 2 system. • Preparation of solutions and culture media. • Handling of Instrumenal of laboratory. Handling of autoclave • Microbiological environmental monitoring. • Disinfectant test. • Strain isolation, identification and validation. Use, control and maintenance of Standard strain. Show less

• MICROBIOLOGYST ANALYST

  • Mar 2008 - May 2011

  • Sterility Test (Finished product- Ophthalmic and injectable, raw materials and irradiated inputs) • Microbiological controls: Finished product, raw materials, purified and potable water. • Test of bacterial endotoxinas LAL (Limulus Amebocyte Lysate) by the Gel Clot method. • Product and processes validation. • Growth promotion test. • Biochemical tests/typification (Gram,s staining, catalasa, oxidasa, cuagulasa, API `s) • Preparation of solutions and culture media. Handling Instrumental laboratory. Handling autoclave and stove of despyrogenate. • Microbiological environmental monitoring. • Sampling. • Thermal registries (Stoves and refrigerators) Show less