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 measures
- Conduct risk assessments for associated QMS elements and ensure timely completion
- Define CAPA actions and perform efficiency checks
- Initiate Change Control procedures for any changes and ensure timely execution and closure
- Handle document change requests and impact assessments across cross-functional departments
- Manage QMS activities in Trackwise software
- Prepare and review Standard Operating Procedures (SOPs), exhibits, and standard formats in TcU to ensure compliance with current Good Manufacturing Practice (cGMP) requirements
- Advise 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 completion
- Supervise all open QMS elements and ensure closure with effective CAPA measures within defined timeline
- Coordinate with Training and Development department for initiation, efficiency, and closure of training
- Perform GEMBA as part of investigations, if required
- Attend and implement training related to Quality Management System (QMS) and cGMP
- Ensure data integrity and compliance of all processes and systems through frequent GEMBA
- Prepare for and participate in internal and external cGMP regulatory audits, respond to auditor queries, and maintain audit preparedness in the function
- Report any safety or hazard concerns to supervisor or relevant individuals in the area
- Perform 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 devices
- Knowledge of current Good Manufacturing Practice (cGMP) regulations
- Strong attention to detail and ability to identify root causes of issues
- Excellent interpersonal and time management skills
- Ability to effectively communicate and collaborate with cross-functional teams
- Proficiency in using Trackwise software or similar QMS platforms
- Familiarity with change control procedures and document management systems
- Consistent record to efficiently implement CAPA measures and drive continuous improvement
- Ability to perform GEMBA investigations and assess data integrity and compliance
- Experience in preparing for and participating in regulatory audits is a plus
- Strong dedication to safety and adherence to protocols and procedures
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.
