Quality Systems Specialist

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Job Description

Job title: Quality Systems Specialist

Location: IRL - Dublin

Job Summary:

The Quality Systems Specialist is responsible for ensuring that the Quality Management System (QMS) for Small Molecule products is compliant with regulatory requirements, is aligned with industry best practices and meets Takeda global expectations. This includes proactively developing, implementing, improving, and maintaining Quality Systems and processes to support manufacture, testing, and release of TILGC products.

Key Responsibilities:

• Lead the development, maintenance, and continuous improvement of a world-class Quality Management System (QMS) at TILGC, leveraging industry best practices and innovative approaches.
• Ensure that all quality systems and processes are documented, implemented, and maintained in accordance with applicable regulations and standards, demonstrating a strong commitment to quality and compliance.
• Work closely with colleagues to provide effective support for the Small Molecule operation.
• Develop monitor and improve the effectiveness of the Quality Management System, driving a culture of data-driven decision making and continuous improvement.
• Lead tier boards and other meetings to drive performance excellence.
• Provide expert guidance and support to cross-functional teams on Quality System requirements and processes.
• Proactively participate in external audits and inspections as needed, demonstrating a strong sense of ownership and accountability for the Quality Management System.
• Develop and deliver engaging training on Quality System requirements and processes, maximising learning outcomes.
• Support change management, maintaining the highest level of product quality and patient safety, including change control coordination, risk assessment, and impact analysis.
• Manage an effective system for corrective and preventive actions (CAPAs), including root cause analysis, action planning, driving closure and effectiveness monitoring.

EDUCATIONAL REQUIREMENTS:

• Bachelor's degree in chemistry, biology or a related scientific discipline.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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