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.

Essential Duties and Responsibilities.  This section contains a list of five to eight primary responsibilities of the work.  The incumbent will perform other duties as assigned.

Key contact for Elemental Impurities in Baxter products for Nutrition and Medication Delivery. Ensure interactions with the different functions (analytical, product owner, regulatory, product development, container,…). Apply a solid understanding of theories/practices including those from other disciplines outside the primary area of expertise.As technical expert, define the strategy for Elemental Impurities for Exploratory, New products and lifecycle of products on the market/Geo-Expansion projects. Maintain compliance with ICH Q3D guideline and with Baxter global strategy.Manage elemental impurities risk assessment for products: creation and updates/review.Support lifecycle and operational activities for products on the market (supplier notice of changes, supplier/material change, manufacturing change,…).Support to manufacturing plants in order to secure Products on the Market.Support Regulatory submission through CMC section writing and answers to Health Authorities on due time.Supervise lifecycle management of analytical methods related to Elemental Impurities in products.Adhere to the Quality Systems, understand and apply applicable corporate and departmental procedures as required.Prepare/review technical protocols and reports.Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) and Elemental Impurities to ensure compliance through the whole life of the product

Qualifications, Education and/or Experience.  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  List knowledge, skills, and/or abilities required. 

  N/A:  Intern or Co-op

Relevant technical discipline, preferably a degree in Chemistry/Pharmaceutics with a a strong technical knowledge on analytical techniques.Present a good knowledge of ICH guidelines, GMPs, FDA guidelines, submission process, quality and general business systems.Technical writing proficiency to author reports and scientific assessments.Strong communication skills. Display ability to communicate effectively using a wide variety of skills and vehiclesAble to work in a team environment and demonstrate an inclusive attitude. Ability to facilitate cross-function/division teamsAppropriately prioritize assignments to meet project schedules. Demonstrates flexibility.Able to operate in Certified environment by complying with quality system in place.Fluent in English.

Reasonable Accommodations

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