QP & Quality Manager Compounding Sandyford Dublin 18

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Your Role at Baxter

This is where your creativity addresses challenges

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. 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.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

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. This is according to Eudralex Volume 4 of "The rules governing medicinal products in the European Union." Follow Commission Directive 2003/94/EEC, its amendments, and any Baxter company requirements.

• Act as a Qualified Person (QP) responsible for implementing the quality management system. Lead all aspects of the compounded products release process. Ensure strict adherence to regulatory and customer requirements.

• 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, preparing the site for audits at any time.

• Lead and manage the audit process for the facility, ensuring that audit findings are thoroughly investigated and addressed promptly.

• Measure and analyze site quality metrics and indicators, comparing performance against targets, and implement data-driven actions for continuous improvement of processes and products.

• 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’ 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.

Attributes:

• 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.

What are some of our benefits of working at Baxter?

• Pension

• Competitive package

• Health Insurance

• Life Assurance and much more.

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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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