Research Associate II, Design Quality

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:

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.
• Continual system improvement and cGxP mindset

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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