Job
Description
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. Responsible for Analytical Method Transfer activity at Baxter and Non-Baxter Manufacturing sites Preparation of method transfer and method verification protocol and report Review of method transfer and method verification protocol and report Review of raw data generated during method transfer Review of API DMF, specification and Method of analysis for API, FP, Excipient and Packaging materials in close co-ordination with CFTs/CMOs. Trouble shooting of the Analytical method for HPLC, GC, IC, ICPMS, Potentiometric technique Method validation of API, excipients and Finished product for regulatory markets; US and Europe Review of Compendial changes, their assessment and implementation at CMOs and plant Review of CMOs change control and approval Collaborate with other functions such as project management, regulatory, formulation, manufacturing, and quality control in project teams Collaborate with Baxter external partners to ensure successful execution of Method transfer and analytical testing Responsible for initiating the Quality Elements like Change and to complete the related tasks with close collaboration with CFT`s Qualificaiton Master’s degree with 10-12 years GxP laboratory/analytical experience Communication skills to build relationships across functional and geographical boundaries and present technical concepts to technical and non-technical teams Writing and computer skills relevant to recording and reviewing of protocols, reports, and presentations to communicate with partners and team members Experience with leading large analytical projects and analytical method validation and transfer A good understanding of ICH, EMEA, EDQM, ANVISA, FDA and compendia (USP/EP/BP) Experience of working with global cross-functional teams and project management is a plus 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. Show more Show less
