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Quality Engineer-Validation

Req #: JR - 032100 Location Tianjin, Tianjin Municipality, China Job Category: Quality Control Date Posted: 12/29/2020

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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Quality Engineer-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 therapiesare foundin almost every hospital worldwide, in clinics and in the home. Forover 85years, we have pioneered significant medical innovations that transform healthcare. 

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

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

Responsibilities

  • Ensure NPVC project compliance with quality management. Ensure production and quality related facilities, manufacturing equipment and analytical equipment are validated according to GMP requirements
  • Set up validation master plan for the NPVC project, ensure the facility, utilities and equipment  are all adequately validated.
  • Implement validation activity for the NPVC project, including review relevant validation document such as URS,IQ, OQ, PQ and coach the validation team to prepare protocol and report to ensure the new facility, manufacturing equipment and analytical equipment is qualified or validated.
  • Establish and maintenance procedure for risk management to describe Quality Management System  for new NPVC project. Perform risk assessment for critical system and process to identify risk to support management decision for quality issues. Make sure use appropriate risk management tools to implement risk assessment during change control, validation, nonconformance investigation process.
  • Maintain the NPVC project validation plan for the utility, facility, process equipment, analytical equipment and analytical method validation etc. Perform periodic review to ensure all are maintained in the validated status.
  • Complete all the validation documents archive  in a timely and ensure the documents in accordance with the compliance requirements.
  • Understand and implement Baxter, division and regulatory EHS requirements as applicable to this position.

Requirements

- At least a bachelor degree in pharmaceutical, medical or chemical.

- At least 2 years of working experience in quality control and quality assurance.

- Good skills on English and computer.

- Good judgment and independent on quality control process.

- Good leadership and human relationship skills.

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.

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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