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Quality Systems Specialist - Compounding

Req #: JR - 134357 Location: Tuscany, Italy Additional locations IT/SES - Italy Sesto Florence Job Category: Quality Date posted: 04/22/2024

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 Systems Specialist - Compounding

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.

SUMMARY

You will provide Quality Systems support to EMEA and Global Compounding organization to ensure that all sites maintain a compliant, efficient Quality Management System (QMS) in accordance with local regulatory requirements for Good Manufacturing Practice and Baxter Global QMS requirements.

You will manage and analyze Compounding quality systems data; reports into EMEA Compounding Quality System Sr Manager.

WHAT YOU'LL BE DOING

- Ensure the effective implementation of the Baxter Quality Management System in Compounding Facilities, in compliance with Global and local Regulatory requirements, by quality data monitoring and analysis (e.g. data collection & analysis of Quality KPIs/Metrics, for Global Compounding (GC) Management Reviews and PRO Site model)

- Quality System coordinator for EMEA & Global Compounding Quality documentation including:

Baxter Global Document Impact and Implementation process (QMSIS) SOP/ BGC and CECOM documents issuance on documentation management system TcU BAXU training course update and assignment GC SharePoint maintenance

- Coordination of Quality Notification to Management (QNTM) escalation process
Qualified Trainer for NCR/CAPA and Change Control processes.

- Other duties in support of Compounding Quality Systems as required, including support to Regional/Global Compounding

WHAT YOU'LL BRING:

  • Data analysis capability
  • Excellent communication skills, include good level of English (written & spoken), Italian and/or French languages advantageous.
  • Critical thinking, results-oriented, pragmatic
  • Ability to operate remotely and within a matrix of colleagues, stakeholders, partners across different functions including site/regional Quality, Operations, Global Quality, Global Sterility Assurance, IT

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.

134357

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.

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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