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QA Specialist (Validation)

Req #: JR - 116639 Location: Rayong, Rayong, Thailand Job Category: Quality Date posted: 11/24/2023

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 Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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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

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QA Specialist (Validation)

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.

Job Scope: This position is responsible for providing Quality support and oversight as well as identifying, assessing, and working to correct small scope regulatory and quality risks.

Job Descriptions:

Validation

  • Maintain the validation database and monitor timely and proper completion of validation record as VMP requirements through the validation cycle.

  • Ensure validation activities are complied with validation protocol. Maintaining re-validation and validation maintenance review schedule to ensure that it will be complied with the requirements.

  • Coach and support cross functional teams on preparing validation documents as per global Baxter requirements.

QA In-process Controls

  • Ensure In-process quality control, final AQL inspection and process to meet follow facility standard procedure and requirement.

  • Decision making for quality event in normal manufacturing basis

  • Review Manufacturing record of Components manufacture to ensure compliance to quality requirements.

  • Responsible for product hold process execution and management.

  • Ensure the implementation of quality assurance aspects to all Quality inspectors

  • Ensure and maintain QA related SOP though document life cycle

Calibration

  • Oversite of calibration process as maintained by QA Associate.

  • Oversite of calibration records management in paper and in CMX software.

Quality team member

  • Perform all other duties of equal or less complexity as assigned or directed

  • Support timely close-out of NCR/CAPA, Change control system, and other quality assurance elements.

  • Engage and retain high-performance standards and elevate level of responsibility and performance

  • Ensure a safe working environment for team, escalate up to manager if there are events risk of unsafety of non-compliance on the product.

Qualifications:
  • Bachelor of Science or any related fields.

  • At least 1 year of QA experience in Validation Process.

  • Excellent written and verbal communication skills

  • Knowledge of calibration tools

  • Good problem-solving skills

  • Analyze and interpret data to complete validation/calibration procedures

  • Good command of English and Computer literacy

  • Problem solving skill and have understanding in GMP requirement.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] 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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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.

Christelle

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.

Lorena

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.

Gary

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.

Christelle

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.

Lorena

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.

Gary

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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