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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.
Job Responsibility
Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use according to Eudralex Volume 4 and Commission Directive 2003/94/EEC
Act as a Qualified Person (QP) responsible for implementing the quality management system and 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 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 implement data-driven actions for continuous improvement
Develop and implement risk management strategies to minimize product and process risks
Coordinate the management, execution, and approval of quality documents and records including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Reports
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