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Analista de garantia de qualidade senior - Validação de limpeza e processo

Req # JR - 169957 Location São Paulo, São Paulo, Brazil Job Category Quality Date posted 05/20/2025
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Analista de garantia de qualidade senior - Validação de limpeza e processo

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This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Sobre nós: A Missão da Baxter

 Na Baxter, estamos profundamente conectados por nossa missão. Independentemente de sua função na Baxter, seu trabalho tem um impacto positivo nas pessoas em todo o mundo. Você experimentará um senso de propósito em toda a organização, sabendo que nosso trabalho melhora os resultados de milhões de pacientes. 

Seu papel na Baxter

Será responsável por realizar as atividades de CPV como coletas de dados, análises estatísticas, elaboração dos relatórios, comitê do CPV.

Seu time:

Desenvolvemos produtos de qualidade com o paciente em mente, então nossos esforços também são centrados no paciente. Isso significa que você pode se orgulhar do nosso trabalho e do valor que fornecemos às pessoas todos os dias.

Como uma grande organização multinacional, você tem a oportunidade de expandir seu conhecimento por meio da colaboração com uma variedade de indivíduos, exposição a diferentes facetas de nosso portfólio e uma equipe de liderança de apoio que incentiva o desenvolvimento contínuo.

O que você vai fazer

-  Estabelecimento de estratégia para validação de processo

 - Estabelecimento de estratégia para validação de limpeza

– Planejamento dos estudos;

- Orientação de colegas;

- Manutenção do CPV, de acordo com guias internacionais e legislação vigente;

- Gestão das atividades de CPV como coletas de dados, análises estatísticas, elaboração dos relatórios, comitê do CPV;

- Suportar a validação em auditorias nacionais e internacionais, incluindo clientes B2B;

- Elaboração e revisão de protocolos e relatórios de validação de processo, validação de limpeza e CPV;

- Acompanhamento e amostragem de lotes de Validação de Limpeza e Validação de Processo;

- Treinamento dos times de diferentes áreas nos conceitos de Validação;

- Investigação de desvios de qualidade e implementação de CAPA;

- Abertura e gestão de controle de mudanças;

- Suportar a revisão de qualidade do produto (RQP), mediante dados de validação e CPV;

- Suporte em integridade de dados para todas as áreas de validação;

- Avaliação e construção de indicadores, elaboração e revisão de POP´s, conferência de documentação BPx relevante.

- Realização de gap análises entre normas corporativas e internas.

- Representação em auditorias internas, corporativas e de clientes

-  Avaliação estatística de resultados (Carta de controle, análise de tendencia, análise de capacidade e performance, teste de equivalência de médias, teste de igualdade de médias - ANOVA, análise de dados não paramétricos, regressão linear)
- Elaboração de análises de riscos (FMEA)

O que buscamos em vocês:

Formação completa em Engenheira ou Farmácia;

Inglês avançado;

Estatística ( Minitab);

Conhecimento geral de Boas Práticas Fabricação, outras legislações local e internacional para medicamentos;

Conhecimento e aplicação de Ferramentas de Qualidade Integridade de dados;

Ferramentas Office;

Experiência na área de Validação/Qualificação na Indústria Farmacêutica por  pelo menos 03 anos.

Horário de trabalho - ADM - 08:00-17:00 seg a sexta

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Address

Explore this location Avenida Engenheiro Eusébio Stevaux 2555
Sao Paulo- SP
04696000
Brazil Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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