Job Description

Job SummaryJob Title Research Associate ILocation Whitefield, BangaloreShift GeneralResearch Associate I within Renal Business, is responsible for technically leading projects/tasks/activities related to product development and lifecycle management of Peritoneal Dialysis products.Duties and Responsibilities

• As Tech Lead or Change Owner, define, organize, plan, and execute activities related to product design change, supplier related changes, new product registration and strategic or value improvement projects in compliance with current international/regional/national regulations with support from senior colleagues as in when necessary.
• Propose, formulate, and coordinate action plan for implementation of changes and related activities by working closely with PDO Organization, Project Management, Regulatory, Quality, senior colleagues, and the other cross-functions.
• Expected to develop, document, test and manage product related changes in accordance with established Renal Care product processes and stay in alignment with Quality Management System.
• Ensure good internal and cross-functional communication and regular status update of activities.
• Establish, maintain, and update Technical Design documentation according to Good Documentation Practices.
• Propose, participate, or lead ideation sessions for product enhancement and exploratory activities to foster innovation culture within team.
• Assist in providing technical support to queries from MOH authorities or auditors (internal/external) in due time by collaborating with cross-functions and subject matter experts.
• Ensure Quality Compliance to Baxter policy/Ethics/Data Integrity.

QualificationsMasters in Science or Pharmaceutical disciplines is required. Must be able to interact on a technical level.Education and Experience

• Masters degree in Science or Pharmaceutical disciplines is required with relevant experience.
• Adequate orientation towards Renal PD therapies and products with time.
• Adequate knowledge of product development stages and life cycle management required for effective collaboration with cross-functions and execution of project deliverables.
• Adequate knowledge of Design Control documentation, Process, and Quality Management Systems.
• Adequate knowledge of international/regional/national regulations and standards.
• Demonstrate Project Management skills in due time.
• Demonstrates flexibility and the ability to shift gears between projects comfortably.
• Excellent oral and written communication skills.
• Good analytical and problem-solving skills
• Good organizational skills. Ability to effectively organize and prioritize tasks.

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