Validation Analyst

3 semanas atrás

Rio de Janeiro, Rio de Janeiro, Brasil Guerbet Tempo inteiro

Press Tab to Move to Skip to Content Link

At Guerbet, we build lasting relationships so that we enable people to live better.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for the last 95 years, we continuously innovate.

Customer centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on LinkedIn, X, Instagram, and YouTube.

WHAT WE'RE LOOKING FOR

We are seeking a proactive and detail-oriented Computerized Systems Validation Analyst (Pleno level) to join our Quality department. In this role, you will ensure compliance with ANVISA RDC 658, IN 134/22, IN 138/22, and international guidelines by validating computerized systems and supporting continuous improvement initiatives. You will also contribute to audits, inspections, and global projects, playing a key role in maintaining the integrity of our validation processes.
This position is based in Rio de Janeiro, is fully on-site, and is a full-time role.

YOUR ROLE
  • Validate both legacy and new computerized systems.
  • Maintain and update the Computerized Systems Validation Master Plan and Inventory.
  • Prepare full lifecycle documentation: planning, risk analysis, functional/technical specifications, qualification protocols, final reports, and periodic reviews.
  • Support and improve BPx system areas.
  • Evaluate change requests and CAPAs related to system validation.
  • Assist in deviation investigations and CAPA processes.
  • Conduct audits to ensure validated status of embedded BPx systems.
  • Participate in inspections and audits related to computerized systems validation.
  • Support Federal Revenue audits to maintain OEA certification.
  • Present EHS topics monthly in DDS meetings and engage in global projects.
YOUR BACKGROUND
  • Education: Degree in Pharmacy, Systems Analysis, Chemistry, or Chemical Engineering.
  • Experience: At least 2 years of experience in Computerized Systems Validation.
  • Advanced knowledge in computerized systems validation.
  • Proficiency in Microsoft Office (Word, Excel, Visio, PowerPoint).
  • Desirable: Knowledge of PLC, HMI, basic programming, IT infrastructure, application servers, and databases.
  • Self-confidence, teamwork, organization, focus, interpersonal skills, and proactivity.
O QUE ESTAMOS PROCURANDOSEU PERFILEQUAL EMPLOYMENT OPPORTUNITY

Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against applicants based on race, color, religion, national origin, sex, age, disability, veteran or military status, genetic information, pregnancy, or any other legally protected basis under federal, state, or local law. The information collected is solely for assessing suitability for employment, verifying identity, and maintaining employment statistics.

Applicants may be entitled to reasonable accommodation due to disability, pregnancy, or related medical conditions, or sincerely held religious beliefs. Please inform our personnel if you need assistance completing this application or participating in the process.

Guerbet will not discriminate against employees or applicants for discussing or disclosing their pay or that of others.

#J-18808-Ljbffr

  • Computerized Systems Validation Specialist

    Há 7 dias

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeValidation Tempo inteiro R$40.000 - R$80.000

    Computerized Systems Validation Analyst Job DescriptionJob Title: Computerized Systems Validation AnalystJob Summary:We are seeking a detail-oriented and proactive Computerized Systems Validation Analyst to join our Quality department. The ideal candidate will have a strong understanding of computerized systems validation principles and experience in...

  • Validation Analyst Job Details

    1 semana atrás

    Rio de Janeiro, Rio de Janeiro, Brasil Guerbet Tempo inteiro

    Validation Analyst - (30115 ) At Guerbet, we build lasting relationships so that we enable people to live better . We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for the last...

  • Validation Analyst Job Details

    3 semanas atrás

    Rio de Janeiro, Rio de Janeiro, Brasil Guerbet Tempo inteiro

    Validation Analyst - (30115 )At Guerbet, we build lasting relationships so that we enable people to live better . We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for the last 95...

  • Operational Key Performance Analyst

    Há 7 dias

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeOperational Tempo inteiro US$82.125 - US$114.515

    Key Performance Analyst Role:The ideal candidate will lead the vendor onboarding and validation process for performance marketing partners.Main Responsibilities:Own and execute vendor onboarding, validation, and integration for performance marketing partnersDesign and maintain data pipelines for key business metricsCollaborate with engineers and growth...

  • Qa Analyst

    1 semana atrás

    Rio de Janeiro, Rio de Janeiro, Brasil Whirr Crew Tempo inteiro

    Get AI-powered advice on this job and more exclusive features. We are seeking a highly skilled QA Analyst to support the quality delivery of the company's internal and external applications. This role will require close collaboration with the development team and global users to ensure functionality, performance, and reliability across legacy and modern...

  • Senior Computer Systems Validator

    Há 21 horas

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeValidation Tempo inteiro R$1.000.000 - R$1.350.000

    Job OpportunityWe are seeking a detail-oriented professional to fill the position of Validation Analyst. This individual will be responsible for ensuring compliance with regulatory guidelines by validating computerized systems and supporting continuous improvement initiatives.

  • Chargeback Analyst

    Há 5 dias

    Rio de Janeiro, Rio de Janeiro, Brasil Patrianna Tempo inteiro

    At Patrianna, we are driven by our passion to deliver world-class gaming experiences to millions of players across the globe. As a dynamic and international team, we embrace a collaborative, remote-working culture, focused on innovation and excellence in everything we do.We are seeking a detail-oriented and proactive **Chargeback Analyst** to join our...

  • Lead Data Pipeline Architect

    Há 5 dias

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeDataEngineer Tempo inteiro R$100.000 - R$150.000

    Job Opportunity: Data EngineerWe are seeking an experienced professional to lead the design, development, and maintenance of data pipelines. This role involves ingesting threat intelligence data from various sources into our data ecosystem.Responsibilities:Develop and implement data validation processes to ensure accuracy, completeness, and...

  • Administrative Analyst

    Há 6 dias

    Rio de Janeiro, Rio de Janeiro, Brasil Wärtsilä Tempo inteiro

    Administrative Analyst**You will focus on these responsibilities**:- Track and monitoring time entries for hundreds employees based in Brazil, Chile, and Argentina- Prepare time sheets events for differents countries pay cycles- Monitor time entry, and follow up with employees to ensure time is entered properly and following local legislation/local policies-...

  • Chargeback Fraud Investigator

    Há 5 dias

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeFraudInvestigator Tempo inteiro R$80.000 - R$100.000

    Chargeback Analyst Job OverviewPatrianna is seeking a detail-oriented and proactive Chargeback Analyst to join our team.Review, investigate, and resolve chargeback disputes accurately and in a timely manner while adhering to rules and regulations.Detect, investigate, and perform risk analysis regarding reported chargebacks and return transactions.Perform...