Quality Associate III – Baxter

Baxter is hiring a Quality Associate III in Bangalore. If you’re skilled in stability studies, LIMS, cGxP compliance, and pharmaceutical quality systems, this is a high-impact role where your work directly contributes to saving and sustaining lives. This opportunity is ideal for professionals in Quality Assurance, Stability Management, and Regulatory Support seeking to grow in a global healthcare organization.

Key Responsibilities

As a Quality Associate III, you will:

• Generate electronic protocols, build studies, manage data entry and review in LIMS, and maintain study files.
• Prepare stability reports, including annual product review and regulatory submission reports.
• Perform stability assessments to support investigations, complaints, change controls, and chamber excursions.
• Develop stability study designs for new and sustaining product development projects.
• Contribute to technical feasibility assessments and analyze results against product requirements.
• Independently plan and execute complex stability study tasks with multiple variables.
• Lead adaptation of new quality techniques to meet cycle-time and compliance goals.
• Train and mentor junior team members, offering expert guidance.
• Develop new approaches to complex quality and stability problems.
• Stay updated with QSR, ICH stability guidelines, and regulatory expectations.
• Participate in the creation and interpretation of regulations and quality standards.
• Prepare budgets and activity schedules for assigned tasks.

Required Qualifications & Skills

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or related fields.
• Strong working knowledge of cGxP, ICH stability guidelines, and QSR requirements.
• Experience with LIMS, stability testing, and pharmaceutical quality systems.
• Ability to manage complex technical tasks independently.
• Strong analytical, documentation, and problem-solving skills.
• Experience mentoring or supervising junior staff (preferred).

Why Join Baxter?

• Opportunity to work with a global leader whose mission is to Save and Sustain Lives.
• Collaborative culture built on trust, courage, innovation, and accountability.
• Work on meaningful projects that directly impact global healthcare quality.
• Professional development in advanced pharmaceutical quality systems.

How to Apply

Application Link