Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.
Post : Quality Associate III
Job Description
Generation of electronic protocols/ study building/ data entry/ data review in LIMS, maintaining study files, preparation of stability reports for registration, annual product review and annual reports for regulatory submissions.
• Perform stability assessments to support laboratory investigations, product complaints, change controls and stability chamber excursions.
• Develop stability study designs for new product development and sustaining product projects. Contribute to technical feasibility analysis of complex research and design concepts. Evaluate results relative to product requirements, definitions and/or program goals.
• Independently plan and execute a series of stability study designs and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines. Play a lead role in the evaluation, selection and adaptation of various techniques/strategies, which accomplish business objectives such as quality and cycle-time.
• May provide training and supervision to junior members within the discipline. Routinely provide advice and assistance to team members regarding unique problems.
• Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving existing or new products/processes.
• Maintain current knowledge of relevant QSRs and other regulatory requirements, such as the stability related ICH guidelines, for R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
• Displays a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise. In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, is able to provide expert advice and/or is an active participant in the generation, review, adoption, and interpretation of such regulations.
• Develop budgets and activity schedules of limited scope. Maintain focus on meeting both external and internal customer expectation.
Additional Information
Req # : JR-184705
Location : Bengaluru, Karnataka, India
Job Category : Research and Development
End Date : 20th November 2025
Quality Associate : Apply here
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