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.

Main purpose of the job.

▪ Batch release approval of pharmaceutical products (pharmacist license mandatory)

▪ Medical device GMP renewal

▪ QMS management.  

Essential Duties and Responsibilities

• Coordinate the timely release of licensed products (pharma products: AS/PD/HP). Check local batch record, and review, or approve on releasing pharma products.
• Review and approve warehouse record (Receiving & Shipping docs).
• PMF update.
• Evaluate new raw materials to develop first of code criteria for raw material testing.
• QMS related work:  Review and approve local procedures (SOPs), and Manage Quality system for Korea, and Support NCR/CAPA, CCM activities
• Responsible for change control activities / documentation. Required to perform review of regulatory documentation applicable to the product of the department.
• Develops and maintains inspection documentation procedures, QA inspection instructions and department policy procedures. Ensures product compliance regulations are followed.
• Coordinate Local Internal audit and Global internal audit as well as inspections by regulatory agencies.
• APQR preparation.
• Medical Device GMP Certification Renewal.
• Support GSQ activities.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] 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.