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Quality Assurance Lead

Req #: 170005RA_en
Location: Braine-l'Alleud, BE
Job Category: Quality
Date Posted: 10/3/2017 3:01:13 AM
Baxter International

Description

Our employees around the world are connected by an enduring commitment to save and sustain lives. This higher purpose binds us as a company in doing work that matters.
Do you want to know why it is so wonderful to work for Baxter? Go to https://www.youtube.com/watch?v=OY89yj_zSIo

The Job

Manage and provide Quality support for the successful completion of new and improved (LCM) product design and implementation projects within boundaries of quality, time and budget. Based on significant quality and compliance expertise, review and approve complex design concepts and provides direction to staff. Recognized as expert by peers and other personnel within the business.
•    Provide Subject Matter Expertise (SME) for Quality for assigned products/therapies to multifunctional teams
•    Provide expertise on the creation of Risk management and Design/Development deliverables to multifunctional teams
•    QA support for implementation of Risk Management initiatives and Quality by Design (QbD)
•    Assisting in further develop and maintain R&D Quality System to ensure compliance with the requirements of the customers, of the authorities and the Corporation (e.g. audits)


More specifically, you will:

Function as Quality Core Team member supporting new and improved (LCM) product design and implementation projects (including potential large programs) and manage a variety of complex issues in associated projects
•    Responsible for defining scope of quality deliverables and support for project team
•    Potentially manage, identify, hire, develop and recognize technical staff
•    Review and approve technical feasibility of complex design concepts and analysis of technologies from a quality expertise perspective, as well as multiple disciplines
•    Identify potential resource needs and need for funds to support job responsibilities
•    Provide Guidance on creation and maintenance product Design History Files and Risk Management Files according to relevant Quality System and other regulatory requirements. Provide guidance to the R&D development group on best practices in risk management and development process deliverables.
•    Lead and approve CAPA projects and participate in CAPA review process.

Qualifications

Who you are

Technical skills

•    Strong analytical and problem solving skills preferably utilizing DMAIC tools; •    General understanding of applied Statistical Methodologies
•    Compliance knowledge in the areas of pharmaceutical product development, change control, CAPA, and risk management
•    Understanding of container requirements for pharmaceutical product registration
•    Project management experience;
•    Individual must be extremely well organized, pay meticulous attention to details, and be able to articulate customer needs and incorporate into work
•    Ability to work with minimal supervision and to make decisions even if provided with limited information

Functional requirements & competencies – Quality Manager

•    Function as Quality Core Team member supporting new and improved product design and implementation projects (including potential large programs) and manage a variety of complex issues in associated projects
•    Responsible for defining scope of quality deliverables and support for project team
•    Manage, identify, hire, develop and recognize technical staff, as required; the team may include quality engineers, associates and technicians
•    Review and approve technical feasibility of complex design concepts and analysis of technologies from a quality expertise perspective, as well as multiple disciplines
•    Review and analyze proposals to determine if benefits derived and possible applications justify expenditures, resource needs, and allocation of funds
•    Provide Guidance on creation and maintenance product Design History Files and Risk Management Files according to relevant Quality System and other regulatory requirements. Provide guidance to the R&D development group on best practices in risk management and development process deliverables.
•    Lead and approve CAPA projects and participate in CAPA review process.
Assisting in further develop and maintain R&D Quality System to ensure compliance with the requirements of the customers, of the authorities and the Corporation (e.g. audits)


What we offer

It is a challenging opportunity for you and also a chance to work in a diverse team with a great mix of people. Joining Baxter means joining a team that you can truly learn from!
We encourage our employees to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers. If you have an interest in this great opportunity and think you can make a difference then this could well be the role for you.
If you want to learn more about career opportunities go to http://www.baxter.com/careers.page

Who we are

Baxter touches millions of lives every day. Our products and services are essential building blocks of healthcare. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide. You’ll find us in clinics and in the home. Patients and providers rely on Baxter for lifesaving renal and medical products.
Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations for the world.
Our 50,000 employees serve patients and clinicians in more than 100 countries and are dedicated to ensuring Baxter is there when patients need care.
Our inclusive culture and a diverse workforce drives innovation, creates trusted partnerships with customers, suppliers, and community partners, and contributes to the success and sustainability of our business.
Every day at Baxter is a chance to save and sustain lives

Equal Opportunity Employer Discrimination: Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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