About the Role
As a QP & Quality Operation Manager, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.
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.
What you’ll be doing
Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use according to Eudralex Volume 4 and relevant regulations.
Act as a Qualified Person (QP) responsible for implementing the quality management system and leading all aspects of the compounded product release process.
Serve as the primary contact with the regulatory agency (HPRA) regarding manufacturing licence, GMP inspections, and potential compounding product quality issues.
Develop and maintain an internal review process to ensure continuous compliance, preparing the site for audits at any time.
Lead and manage the audit process for the facility, ensuring findings are investigated and addressed promptly.
Measure and analyze site quality metrics and indicators, implementing data‑driven actions for continuous improvement.
Develop and implement risk management strategies to minimize product and process risks, ensuring patient safety.
Coordinate the management, execution, and approval of quality documents and records for the site, including Nonconformance investigations, CAPA plans, change controls, SOPs, validation protocols, and reports.
What you’ll bring
6‑10 years of experience in quality implementation in the pharma industry.
Proven knowledge of applicable regulations and standards, e.g., EU GMP Annex 1, especially in relation to aseptic manufacturing environments.
Proven aseptic manufacturing experience with knowledge of 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.
Attributes
Strong leadership skills to motivate teams, make decisions, and guide the organization toward quality objectives.
Excellent organizational skills for managing tasks, coordinating resources, and ensuring prompt, data‑driven decision making.
Excellent communication and interpersonal skills to build relationships with collaborators and facilitate collaboration with other compounding functions.
Benefits
Pension
Competitive package
Health insurance
Life assurance and more
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 contact us with the nature of your request and your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams involving fraudulent parties posing as Baxter employees, recruiters, or agents. To protect yourself, review our Recruitment Fraud Notice.
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