Research Associate III, Baxter

Baxter

Location:

Malta, Marsa

Category:

Research and Development

Contract Type:

Employment contract

Salary:

Not provided

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Job Description:

Research Associate III role at Baxter involves contributing to the development of new knowledge in Research and Development teams, managing elemental impurities in Baxter products, ensuring compliance with ICH Q3D and Baxter strategies, supporting regulatory submissions, and adhering to quality system regulations. The position is located in Marsa, Malta and is deeply connected to the mission of saving and sustaining lives.

Job Responsibility:

Key contact for Elemental Impurities in Baxter products for Nutrition and Medication Delivery
Define strategy for Elemental Impurities for Exploratory, New products and lifecycle of products on the market/Geo-Expansion projects
Manage elemental impurities risk assessment for products including creation and updates/review
Support lifecycle and operational activities for products on the market
Provide support to manufacturing plants
Support Regulatory submission processes including CMC section writing and responses to Health Authorities
Supervise lifecycle management of analytical methods related to Elemental Impurities in products
Adhere to the Quality Systems and apply corporate and departmental procedures as required
Prepare/review technical protocols and reports
Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development and Elemental Impurities

Requirements:

Degree in Chemistry/Pharmaceutics with strong technical knowledge on analytical techniques
Good knowledge of ICH guidelines, GMPs, FDA guidelines, submission process, quality and general business systems
Technical writing proficiency to author reports and scientific assessments
Strong communication skills
Ability to work in a team environment and demonstrate an inclusive attitude
Ability to facilitate cross-function/division teams
Ability to prioritize assignments to meet project schedules
Flexibility to adapt to dynamic environments
Ability to operate in a certified environment by complying with quality systems
Fluency in English

What we offer:

Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Additional Information:

Job Posted:

March 21, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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