Associate I, Design Quality

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Responsibilities:

Major responsibilities are as mentioned below but not limited to,

• Review and approval of technical documents of GPRD which includes analytical and formulation documents.
• Perform tool based investigations for CMO, R&D, plant, and contract labs to ensure compliance with cGxP regulations and guidelines.
• Review and approve QMS documents such as change controls, investigations, and audit reports in TrackWise.
• Handle market complaints and manage the quality management system (change control, CAPA, deviations, OOS, etc.).
• Coordinate with external/internal auditors and ensure timely closure of audit findings.
• Provide expert advice on cGxP regulations and guidelines.
• Prepare, review, and implement SOPs.
• Carry out internal quality audits of R&D lab and maintain Good Laboratory practices.
• Review and approval of risk assessments for commercial product support.
• Risk management, human factor, accelerated aging study, pFMEA, distribution study, sterilization assurance, etc. documents review.
• Monitor and evaluate the performance of process and analytical methods to identify any issues or deviations.
• Collaborate with other departments to ensure that all methods and procedures are compendial compliant.
• Represent subject matter expertise in the areas of process and Analytical (Validation, Verification, and Transfer) as a Quality SME internally and externally as needed.
• Compliance verification through GEMBA walks.
• Handling of SNC’s (Supplier Notification of change).
• Review and approval of Packaging development documents and data along with procedures.
Review and approval of registration and commercial stability data along with trend analysis.

Requirements:

• Master or Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or a related field.
• At least 8-15 years of experience in Quality Assurance or related field.
• In-depth knowledge and understanding of cGxP regulations and guidelines.
• Excellent communication and interpersonal skills.
• Strong technical knowledge, investigational and problem-solving skills.
• Ability to work in a team environment.
• Proficient in Microsoft Office and other quality management systems.
• Proficiency in Microsoft Office and TrackWise8

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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.

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