Research Associate II, stability

Job Summary

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.

Responsibilities

• 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 RD (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.
• 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.
• 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.
• Collaboration with cross functional teams such as QA, MQ, 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.
• Implement new or improved techniques and procedures around specific tasks; write and implement SOPs. Implement research outlines for large scientific projects. Apply state of the-art techniques in expertise to develop new or improved products.
• Able to handle the NCR/sNCR and Change controls.

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