Research Associate Ii

5 months ago

Ahmedabad, India BAXTER Full time

**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.

To provide support to the Stability Team in day to day technical and operational activities.

Develop stability study designs for new product development and sustaining product projects.

Without assistance, make sound technical recommendations regarding stability study designs for new product development and sustaining product projects that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.

Employ appropriate techniques/methods to successfully and independently execute routine assignments related to stability study design and development within negotiated deadlines. Identify alternative methods and technologies for improving existing or new products/processes.

Maintain current/working 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.

Recommend appropriate study designs, techniques, and processes for a specified sequence of tasks where needed, including the use of LIMS systems for electronic stability protocols.

Contribute to technical feasibility analysis of complex products.

Evaluate results relative to product requirements, definitions and/or program goals.

Providing technical rationale for expiration dating and label storage statement recommendations, preparing regulatory submissions, responding to regulatory communications.

Ensuring compliance related deliverables are completed on schedule and per plan.

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.

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, can be able to provide expert advice and/or is an active participant in the generation, review, adoption, and interpretation of such regulations.

Maintain focus on meeting both external and internal customer expectations.

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.

Providing technical rationale for expiration dating and label storage statement recommendations,

preparing regulatory submissions, responding to regulatory communications.

Ensuring compliance related deliverables are completed on schedule and per plan.

Collaboration with cross functional teams such as QA, M&Q, Regulatory, Quality control, and all the projects.

Coordinate stake holders to progress the projects and internal activities in a right direction to achieve the organizational requirement.

To follow all the relevant cGxP and related regulations.

Lead the analytical problem-solving efforts to meet urgent business needs.

Focus on innovation, process improvement, and/or operational excellence initiatives.

Independently plan, execute, and manage projects/programs that both span multiple disciplines and utilize established methods, techniques, or approaches.

Able to handle the NCR/sNCR and Change controls.

**Reasonable Accommodations**

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