Bruna Da Mata

Bruna Da Mata Email and Phone Number

Software Validation Manager @ Curadel Pharma
State of Goiás, Brazil
Bruna Da Mata's Location
Anápolis, Goiás, Brazil, Brazil
Bruna Da Mata's Contact Details

Bruna Da Mata work email

Bruna Da Mata personal email

About Bruna Da Mata

IT Analyst, with 11 years of experience in Pharmaceutical Industry working with Computer System Validation.Responsible for elaboration, execution and management of the following documents, but not limited to: Risks management, protocols and reports (IQ, OQ and PQ), Traceability Matrix, final Validation Report and Change Controls. Review and approval of documents as SOP's and URS (User Requirement specification), based on the GAMP5 guide (Good Automated Manufacturing Practice). Responsible for the system validation of HPLC equipments (High Performance Liquid Chromatography) and Document Management System (DMS), from specification, validation, migration, training and Go-live. Maintenance of the validation state of computerized systems, based on change control, ensuring that they adequately perform their functions, traceability, information/process security and data integrity, following the concepts of the GAMP5 guide and regulatory requirements of ANVISA and FDA.Since 2009, working with software documentation, elaboration of functional software specification, creation and executions of testes to validate and approve, user training and Go-live.Experience with Software UML creation for software documentation, using software Jude (Astah). My expertise is related in Computer System Validation and knowledge in the areas of Change Controls, Audits, Quality Risk Assessments, Data integrity and rastreability.Knowledge in international guidelines FDA, since I work to Teuto and Pfizer, during the period of 2012 to 2017.

Bruna Da Mata's Current Company Details
Curadel Pharma

Curadel Pharma

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Software Validation Manager
State of Goiás, Brazil
Bruna Da Mata Work Experience Details
  • Curadel Pharma
    Software Validation Manager
    Curadel Pharma
    State Of Goiás, Brazil
    View
  • Laboratório Teuto Brasileiro S/A
    Senior Information Technology Analyst
    Laboratório Teuto Brasileiro S/A Mar 2012 - Apr 2023
    Anápolis Area, Brazil
    Responsible for the management, elaboration and execution of documents as risks management, test plan and protocols, test summary reports, traceability matrix, final validation report, change controls, following the concepts of the GAMP5 guide and regulatory requirements of ANVISA. Knowledge of the process and legal requirements for pharmaceutical industry (cGMP's, 21CFR part 11, GAMP).Validation of CSV throughout the whole project cycle (Risk analysis, IQ, OQ, PQ) to ensure compliance and adherence with applicable guidelines.Review and approval of discrepancies, events, non-conforming situations occurring during the tests execution of computer system.Also, part of the team, who is responsible to validate the system of HPLC (High Performance Liquid Chromatography). Software documentation elaboration as functional software specification, black box software testing (elaboration/execution).Responsible for the validation of the Document Management System (DMS), from certification, validation, migration, training and Go-live.Part of the company’s internal audit team.Experience with validation of HVAC (Heating, ventilation and air conditioning) system.
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  • Interagi Tecnologia
    Developer
    Interagi Tecnologia Feb 2011 - Oct 2011
    System Analysis and new requirements, Functional Software Specification, Black Box Software Testing (Elaboration and Execution).Analysis of customer processes. Prototyping of new software functions for development, user training and software support.
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  • Centro Universitário De Anápolis - Unievangélica
    Trainee - Turing Technologies Factory
    Centro Universitário De Anápolis - Unievangélica Aug 2009 - Jan 2011
    Trainee in software development at University, which use Scrum as methodology of development, responsible of the team before the coordinator and other members, worked as P.O. (Product Owner).Software specification of software to attend the administrative routines of the Laboratory of clinical analysis of University, also responsible to elaborate UMLs (use case diagram, activity diagram), all the documentation to team's tasks and preparation of tests for approval of deliveries.

Bruna Da Mata Skills

Sql Mysql Uml Scrum Postgresql Itil Gamp Sistemas De Qualidade Integridade De Dados Testes Manuais Test Cases Test Planning Diagrams Functional Requirements Use Case Change Management Computer Science Standard Operating Procedure Software Validation

Bruna Da Mata Education Details

Frequently Asked Questions about Bruna Da Mata

What company does Bruna Da Mata work for?

Bruna Da Mata works for Curadel Pharma

What is Bruna Da Mata's role at the current company?

Bruna Da Mata's current role is Software Validation Manager.

What is Bruna Da Mata's email address?

Bruna Da Mata's email address is br****@****ail.com

What schools did Bruna Da Mata attend?

Bruna Da Mata attended Universidade Federal De Goiás, Centro Universitário De Anápolis - Unievengélica, Dtu - Technical University Of Denmark.

What skills is Bruna Da Mata known for?

Bruna Da Mata has skills like Sql, Mysql, Uml, Scrum, Postgresql, Itil, Gamp, Sistemas De Qualidade, Integridade De Dados, Testes Manuais, Test Cases, Test Planning.

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