QP & Quality Manager Compounding Sandyford

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About the Role

We are excited to offer an outstanding opportunity for a motivated and experienced person to become our QP and Quality Lead Compounding in Dublin, Ireland. This position is crucial for upholding the highest quality and compliance levels at our compounding site. It follows Good Manufacturing Practice (GMP), European Legislation, and Baxter Healthcare Ltd Standards.

Key Responsibilities

As the QP and Quality Lead Compounding, you will have the responsibility for:

• Guaranteeing that the compounding site meets Good Manufacturing Practice standards for Medicinal Products for Human Use, as outlined in Eudralex Volume 4. This involves following Commission Directive 2003/94/EEC, its amendments, and Baxter company rules.
• Implementing the quality management system and coordinating the release process of compounded products, ensuring adherence to regulatory requirements, relevant specifications, and customer needs.
• Communicating with regulatory agencies (HPRA) regarding Manufacturing Licences, GMP inspections, and any compounding product quality-related issues.
• Leading the audit process for the facility. Ensuring the site team is prepared for audits. Investigating and addressing audit findings promptly.
• Measuring and analyzing site quality metrics and their performance versus targets, and driving continuous improvement of processes and products through relevant indicators.
• Developing and implementing risk management strategies to ensure process risk reduction and patient safety.
• Coordinating, performing, and approving quality documents and records for the site, including nonconformance investigations, CAPA plans, change controls, SOPs, validation protocols, and reports.
• Supporting facility projects, including process development and quality improvement initiatives.
• Promoting a culture of quality awareness and dedication among all site staff, consistently advocating for quality culture.
• Defining QA goals for the site in accordance with Baxter's organizational framework.
• Managing local QA resources and QP, measuring their performance, and providing necessary training and development.

Education and Qualifications

To be successful in this role, you will need:

Required:

• Eligibility to work in Ireland on a full-time basis.
• Bachelor’s degree in pharmacy or a science-related field.
• Certification as a Qualified Person (QP) following EU GMP standards or an equivalent qualification.

Preferred:

• Advanced degrees (e.g., Master's or Ph.D.) in a relevant field.

Experience and Skills

• 6-10 years of experience in Quality implementation within the Pharma industry.
• Proven knowledge or experience with applicable regulations and standards, particularly EU GMP Annex 1, related to aseptic manufacturing environments.
• Proven experience in aseptic manufacture with knowledge in sterility assurance and risk management.
• Demonstrated leadership experience with a track record of meeting results.
• Ability to thrive in a fast-paced environment and prioritize multiple tasks.
• Proven ability to manage and supervise a large and diverse team.

Attributes

• Strong leadership skills to motivate teams and guide the organization toward quality objectives.
• Excellent organizational skills for managing tasks and resources.
• Outstanding communication and interpersonal skills to build relationships and facilitate collaboration.
• Strong work ethic and flexibility to meet business needs.

“What are some of our benefits

of working at Baxter?

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance
• Pension
• Health Insurance
• Life Assurance

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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