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Summary:
Research Associate I is responsible for evaluation of the SNC/proposed change (PI) for commercialized products and drive the change from initiation through closure.
Essential Duties and Responsibilities:
- As 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.
- Assess Supplier Notice of Changes
(
SNCs)/Proposed Initiatives (PIs) and drive the change from initiation through closure by initiating the change control, ensuring applicable assessment(s) are completed by appropriate assessors, conduct design review, implement the change and close the change control on time. - 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, CMOs, and the other cross-functions.
- Expected to develop, document, test and manage product related changes in accordance with established Baxter 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.
- 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.
- Propose, participate, or lead ideation sessions for product enhancement and exploratory activities to foster innovation culture within team.
Qualifications:
- Master’s in science or Pharmaceutical disciplines is required. Must be able to interact on a technical level.
Education and/or Experience:
- Master’s degree in science or pharmaceutical disciplines is required with relevant experience of 4-6 years.
- 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.
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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