Baxter Pharmaceuticals Job Opening For Research Associate - R&D
Post: Research Assoc II, R&D
Location Ahmedabad, Gujarat, India
Job Category: Research and Development
Essential Duties and Responsibilities.
Develops design stability study strategies for research projects, which are non-routine within areas of expertise to address specific technical requirements of a project.
Studies, designs and recommendations reflect impact by and to related disciplines.
Displays a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise.
Represent R&D Stability function as member of project teams. Actively participate in success of project team goals.
Contribute to technical feasibility analysis of complex research and design concepts. Design stability studies used to establish expiration dating for new product development.
Independently plan and execute a series of design and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines. Prepare stability assessments and requirements for new product or product changes.
Prepare stability protocols and reports, stability trending analysis
Work with global stakeholders and manufacturing sites to support registration stability for new product and on market product stability
Evaluate results relative to product requirements, definitions and/or program goals. Perform stability data trend reviews for stability studies in support of new product development or product changes.
Support the development of technical justifications for expiration dating for new or modified products.
Lead laboratory investigations of suspect stability data and/or author technical evaluations that characterize the stability trending of suspect data.
Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality and cycle time.
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 related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
Develop an in-depth knowledge and understanding of GxP and related regulations and guidance.
Develop budgets and activity schedules of limited scope.
May provide training and supervision to team members within the discipline. Routinely provide advice and assistance to team members regarding unique problems.
Maintain focus on meeting both external and internal customer expectations.
Qualifications / Experience and/or Background
Post-Graduation in Pharmacy/Science with proven 8-12 years of experience in Stability Function.
Strong verbal and written communication skills and the ability to organize and effectively communicate complex information to internal and external customers.
Possess relevant laboratory/technical and computer skills.
Must demonstrate flexibility and the ability to shift gears between projects and multi-task comfortably.
Knowledge of such principles as GMPs and FDA guidelines.
Experience with ICH guidelines as related to the quality components associated with pharmaceutical development.
Prior experience and understanding with LIMS software is desirable.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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