Req #: JR - 037975 Location Braine-l'Alleud, Wallonia, Belgium Job Category: Quality Control Date Posted: 04/06/2021 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...
Req #: JR
- 037975 Location Braine-l'Alleud, Wallonia, Belgium Job Category: Quality Control Date Posted: 04/06/2021
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
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.
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
Ensure Quality Assurance for the successful completion of new product development projects and product lifecycle management projects within boundaries of quality, time and budget.
Implement and maintain the Baxter R&D Europe Quality System to ensure compliance with the requirements of authorities and internal customers for drugs and medical devices
Essential Duties and Responsibilities
Provide Guidance to multifunctional teams to ensure that Quality processes are implemented to meet requirements for new product development and lifecycle management for drugs and medical devices under ICH, 21 CFR, EMA, ISO 13485 and 14971, MDSAP &MDR
Ensure Quality processes are correctly implemented on site to meet requirements for pharmaceutical product testing and release.
Review documentation for accuracy and compliance to procedures (analytical methods development/validation/transfer, stability studies, Design & Development).
Prepare and evaluate Product Quality Reviews
Demonstrate compliance of development processes and change control management during audits and inspections, participate as auditor in internal audits and in follow-up activities
Provide Guidance on maintenance of product Design History Files and Risk Management Files according to Quality System and relevant regulatory requirements for therapeutics and medical devices.
Act as QA Approver for Laboratory Out of Specification (OOS), for Product Quality and Quality System Change Controls (CC) and in Non
- conformance or /Corrective Action Preventive Action (CAPA)
Qualifications
Degree in Engineering or in Sciences (Pharmacy, Chemistry, Biochemistry?)
English is a must, French/Dutch is nice to have
3 years in Pharmaceutical/medical devices industry per EU and/ or FDA requirements (GLP/GMP/ISO13485 regulation)
Experience in Quality Initiatives (processes, systems, improvements) is a must
QP certification is a plus
Analytical method development/validation, laboratory activities or stability studies is an asset
Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally.
Individual must be extremely well organized, and be customer focused with strong interpersonal skills.
Ability to work with minimal supervision
Compliance knowledge in the areas of pharmaceutical product development, laboratory control, change control, CAPA
R&D minded
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 ********** and let us know the nature of your request along with your contact information.
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 ;
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' ;
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 ;
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Learn about the four key components of our global inclusion strategy.
Baxter touches the lives of millions of people around the world every day.
Our company is enriched by a diverse population of individuals in more than 100 countries.
Patients? journeys inspire our work and drive our commitment to advance new standards of care.
Heroic work by healthcare providers and first responders to care for those with COVID-19 inspires us all.

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