Quality Associate Iii

0-2 years

Not Disclosed

Bengaluru

10 Oct. 30, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Associate III

Req ID: JR - 184705
Location: Bengaluru, Karnataka, India

About Baxter

At Baxter, we believe every person—regardless of background—deserves a chance to live a healthy life.
This belief has guided us since 1931 and continues to inspire our innovations in healthcare delivery.

Our colleagues are united by our Mission to Save and Sustain Lives and driven by a culture of courage, trust, and collaboration.
Every individual is empowered to make a meaningful impact, ensuring that our operations are efficient, effective, and accountable.

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

Overview

Baxter’s Research and Development (R&D) teams work cross-functionally to innovate, develop, and deliver solutions that address patient needs globally.
From scientists to engineers, every role contributes to creating products that save and sustain lives.

Employee Benefits

Support for Parents
Continuing Education & Professional Development
Employee Health & Well-being Benefits
Paid Time Off
2 Volunteer Days per Year

Success Profile

Successful R&D team members at Baxter demonstrate:

Courage
Action Orientation
Collaboration
Innovation
Ability to Manage Ambiguity
Drive for Results

Job Summary

As a Quality Associate III, you will play a key role in ensuring quality compliance and stability management across Baxter’s product lines.
You will support stability programs, regulatory submissions, and quality system documentation aligned with cGxP and ICH guidelines.

Key Responsibilities

1. Stability Study Management

Generate electronic protocols, study builds, data entry, and data reviews in LIMS.
Maintain study files, prepare stability reports for:
- Product registration
- Annual product reviews
- Annual regulatory submissions
Perform stability assessments to support:
- Laboratory investigations
- Product complaints
- Change controls
- Stability chamber excursions

2. New Product Development Support

Develop stability study designs for new products and sustaining projects.
Contribute to technical feasibility analysis of complex research or design concepts.
Evaluate data relative to product requirements and program goals.

3. Technical & Project Execution

Independently plan and execute complex study designs or technical tasks with multiple variables and limited definitions.
Lead evaluation, selection, and adaptation of various techniques and strategies to meet business objectives such as quality and cycle time.

4. Mentoring & Leadership

Provide training and supervision to junior team members.
Offer guidance on solving unique technical or procedural problems.

5. Continuous Improvement & Innovation

Devise new approaches to complex problems through adaptation of technical principles.
Incorporate emerging technologies and methods to enhance products and processes.

6. Regulatory Compliance

Maintain up-to-date knowledge of:
- QSRs (Quality System Regulations)
- ICH Stability Guidelines
- Other relevant global regulatory requirements for R&D and product development
Ensure compliance in all research, data collection, and reporting activities.

7. Cross-Functional Knowledge

Demonstrate understanding of theories and practices from multiple disciplines outside primary expertise.
Provide expert input during regulatory interpretation, review, and adoption of new quality systems.

8. Budget & Planning

Develop budgets and activity schedules of limited scope.
Focus on meeting internal and external customer expectations efficiently.

Required Knowledge & Skills

Deep understanding of cGxP, ICH Stability, and QSR requirements.
Proficiency in LIMS and electronic data systems.
Strong analytical, problem-solving, and documentation skills.
Ability to independently manage complex projects.
Excellent communication and mentoring abilities.

Equal Employment Opportunity

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

Reasonable Accommodations

Baxter is committed to providing reasonable accommodations to individuals with disabilities throughout the application and interview process.
If you require accommodations, please contact us with your request and contact details.

Recruitment Fraud Notice

Be aware of employment scams where fraudulent parties pose as Baxter representatives to collect personal or financial information.
Refer to Baxter’s official Recruitment Fraud Notice to learn how to protect yourself.

Work Location

Address:
Tower B, 16th Floor
Bengaluru, Karnataka – 560 048
India

How to Apply

👉 Apply Now via the Baxter Careers Portal
💾 Save Job for later review

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Quality Associate Iii

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