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.

Responsibilities:

Prepare and review manufacturing investigations related to NCR/OOS/OOT/OOL/market complaints to identify the root cause and implement appropriate CAPA measuresConduct risk assessments for associated QMS elements and ensure timely completionDefine CAPA actions and perform efficiency checksInitiate Change Control procedures for any changes and ensure timely execution and closureHandle document change requests and impact assessments across cross-functional departmentsManage QMS activities in Trackwise softwarePrepare and review Standard Operating Procedures (SOPs), exhibits, and standard formats in TcU to ensure compliance with current Good Manufacturing Practice (cGMP) requirementsAdvise the supervisor promptly of any delays in investigations or QMS elements to ensure timely resolution.Complete training on assigned SOPs in BAXU system and ensure team completionSupervise all open QMS elements and ensure closure with effective CAPA measures within defined timelineCoordinate with Training and Development department for initiation, efficiency, and closure of trainingPerform GEMBA as part of investigations, if requiredAttend and implement training related to Quality Management System (QMS) and cGMPEnsure data integrity and compliance of all processes and systems through frequent GEMBAPrepare for and participate in internal and external cGMP regulatory audits, respond to auditor queries, and maintain audit preparedness in the functionReport any safety or hazard concerns to supervisor or relevant individuals in the areaPerform tasks assigned by management as needed

Requirements:

Bachelor's degree or equivalent experience in a relevant field (e.g. Manufacturing, Quality Assurance)Experience in a manufacturing role, preferably in a regulated industry such as pharmaceuticals or medical devicesKnowledge of current Good Manufacturing Practice (cGMP) regulationsStrong attention to detail and ability to identify root causes of issuesExcellent interpersonal and time management skillsAbility to effectively communicate and collaborate with cross-functional teamsProficiency in using Trackwise software or similar QMS platformsFamiliarity with change control procedures and document management systemsConsistent record to efficiently implement CAPA measures and drive continuous improvementAbility to perform GEMBA investigations and assess data integrity and complianceExperience in preparing for and participating in regulatory audits is a plusStrong dedication to safety and adherence to protocols and procedures

About Baxter Healthcare Corporation:

Baxter Healthcare Corporation is a world-class manufacturing company dedicated to improving the lives of patients around the globe. With a focus on delivering outstanding healthcare solutions, we strive for detailed execution in everything we do. As an ambitious organization, we compete in the global market and are determined to maintain our position as a leader in the industry. At Baxter, we value teamwork, inclusion, and the proven track record to successfully implement quality management systems. Join our team in Ahmedabad and contribute to our mission of providing innovative and life-saving products to patients in need.

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.