This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. You will play a crucial role in maintaining top quality and compliance in our manufacturing processes. This outstanding opportunity lets you work in a dynamic environment passionate about innovation and excellence. You will lead efforts to ensure our compounded sterile preparations meet strict European Legislation and Baxter Healthcare Ltd Standards.
Job Responsibility:
Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use according to Eudralex Volume 4
Act as a Qualified Person (QP) responsible for implementing the quality management system
Lead all aspects of the compounded products release process
Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential compounding product quality issues
Develop and maintain an internal review process to ensure continuous compliance
Lead and manage the audit process for the facility
Measure and analyze site quality metrics and indicators
Develop and implement risk management strategies to minimize product and process risks
Coordinate the management, execution, and approval of quality documents and records for the site
Requirements:
6-10 years’ experience of Quality implementation in Pharma industry
Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments
Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management
Proven leadership experience with a track record of consistently meeting results
Ability to operate effectively in a fast-paced environment and prioritize multiple tasks
Proven ability to manage/supervise a large and diverse team of employees
Strong leadership skills to motivate teams, make decisions and guide the organization toward quality objective
Excellent organizational skills for managing tasks, coordinating resources, and ensuring prompt quality data driven decision making
Excellent communication and interpersonal skills to build relationships with collaborators and facilitate collaboration with other Compounding functions