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. Sr, Spec, Quality - Compliance  To perform internal quality audits to ensure the compliance to all systems and procedures and ul􀆟mately build the quality focused and ensure appropriate CAPA is placed.  To ensure that system and facili􀆟es comply as per the regulatory requirements and expecta􀆟ons.  To ensure cGMP compliance status of site as per regulatory requirements.  To ensure and sustain all 􀆟me ready plant in line with current regulatory expecta􀆟ons for regulatory authori􀆟es and other partner inspec􀆟on.  To verify process and systems are complying standard opera􀆟ng procedures (SOPs) and current regulatory requirements and expecta􀆟ons.  To ensure that audit observa􀆟on compliance and effec􀆟veness of CAPA.  To perform external audit related process.  To perform GEMBA round of site and report in case of any non-conformance observed during round.  To perform periodic assessment of the GMP trends.  To perform the assessment of regulatory intelligence program and global observa􀆟on cer􀆟fica􀆟on.  To ensure that the required ini􀆟al and con􀆟nuing training of personnel is carried out and adapted according to need.  To impart training to personnel regarding enhancement in regulatory guidelines, system, and processes.  To handle electronic QMS modules for review and approval of changes, procedures etc. To ensure that data integrity is being maintained at all level and to perform / get performed regular checks to ensure that system is in state of control. 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