Job Description

This is where you save and sustain livesAt 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.Essential Duties and Responsibilities:

• Manage change control associated to laboratory processes (test method assay updates, pharmacopoeia changes,..) as per project needs and agreed timeline.
• Participate to the R&D analytical studies through review of protocols, experiments and reports.
• In collaboration with Laboratory and Quality SME, act as:

• laboratory investigation Owner
• Non-Conformance Owner
• Corrective and Preventive Action Owner

• Review local and global procedures as part of periodic review, collect Subject Matter Expert feed-back and take appropriate actions if there is an impact for the laboratory activities execution.
• Contribute to the continuous quality process improvement within R&D analytical laboratories
• Be part of a team which is acting as primary point of contact for quality questions within R&D analytical laboratory teams
• Participate to lab work sporadically upon needs
• Create and maintain project schedules in conjunction with the Laboratory Management and analytical SME. Show project progression and track project risks.
• Coordinate project documentation.
• Maintain knowledge of relevant QSR and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
• Support laboratory team performance through efficient collaboration

Qualification:

• Ability to organize complex information and proven attention to detail
• Apply a logical, methodical approach in solving problems, developing solutions and making recommendations
• A good understanding of ICH, Ph. Eur, USP guidelines and cGxP practice.
• Ability to relate and work well within cross functional team
• Ability to work in agile environment (prioritization of quick delivery, adaptation to changes and collaboration rather than top-down management)
• Quality oriented

Education:

• Master in Science: for instance, Analytical, Organic chemistry, Biochemistry, Bio-engineering, Pharma Science
• 3-5 years of experience in pharmaceutical industry, R&D, manufacturing
• Demonstrate Quality and compliance-oriented accomplishments
• Possess basic understanding of analytical chemistry including theoretical knowledge and practical experience
• Knowledge of GLP and GMP is a must
• Fluent spoken, read and written English is a must.
• Trackwise knowledge is an asset

Reasonable AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter 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 .

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