Research Associate II, stability

Baxter International Inc.; Ahmedabad District; Sur place; INR 1 800 000 - 2 400 000; Plein temps

Résumé du poste

Baxter International Inc. is seeking an experienced stability expert to support a stability team in day-to-day technical and operational activities in India.

The role requires an M.Pharma with 8+ years’ experience in stability, leading study designs and regulatory alignment. You will collaborate across Regulatory, Quality, and project teams to drive compliant, timely results.

Qualifications

• M.Pharma with 8+ years’ experience in Stability.
• Independently plan and execute stability study designs and related tasks.
• Lead evaluation and adaptation of techniques to meet business objectives.
• Strong understanding of regulatory requirements and guidance (ICH, etc.).
• Maintain focus on customer expectations and regulatory deliverables.

Responsabilités

• Develop stability study designs for new product development and sustaining projects.
• Provide sound technical recommendations for stability study designs.
• Execute routine assignments with appropriate techniques and within deadlines.
• Maintain knowledge of regulatory requirements to ensure compliance in data reporting.
• Recommend study designs and processes for specified tasks.
• Collaborate with cross-functional teams across Regulatory, Quality, and other projects.

Connaissances

Stability

Regulatory knowledge

Project management

Cross-functional collaboration

Formation

M.Pharma

Description du poste

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

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

Your Role at Baxter

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

What you'll be doing:

• 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 and other regulatory requirements, such as the stability related ICH guidelines, for (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 systems for electronic stability protocols.
• Contribute to technical feasibility analysis of complex products.
• Demonstrate ability to apply technical theories and principles to projects within area of Expertise for nonroutine tasks. Analyse and determine best solutions to non-routine experimental design or research problems with minimal assistance. Accurately assess results for validity and conformance to specifications
• 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.

What you'll bring:

• M.Pharma with 8+ years’ experience in Stability
• 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 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 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 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.
• Implement new or improved techniques and procedures around specific tasks; write and implement S Implement research outlines for large scientific projects. Apply state of-the-art techniques in expertise to develop new or improved products.

Equal Employment Opportunity

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

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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