Quality Specialist

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Quality Specialist

Dublin, Ireland

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Business Area Overview

At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma Collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

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  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

Quality Specialist

Job ID R0073259 Date posted Sep. 23, 2022 Location Dublin, Ireland

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Job Description

About the role

  • The Quality Systems and Compliance team team is  responsible for for Quality Systems and Compliance for Biologics product in Takeda’s external sites and external contract manufacturing and testing organisation for Drug Substance, Drug Product and Finished Drug product manufacturing.

  • This team will work with our external CMO /CTL partners and internal Quality teams within this department .In addition this function works closely with Global Systems and Compliance, External Supply , Supply Planning, Technical support and other stakeholders involved in external supply.

How you will contribute:

  • This individual is responsible for executing deliverables for Quality Systems and compliance across global external supply including our CMO and CTL partners

  • Responsible for delivering Biologics external supply inspection readiness and execution. The scope of this role includes Takeda  external Biologics locations, and global CMOs /CTLs, for inspections performed by both Health Authorities and business partners.

  • Responsible for Quality Systems supporting external supply , for example, deviation and change control systems, APQRs, Quality Council ,risk mitigation and QTAs/inter company agreements

  • Responsible for reporting and driving improvement processes for quality metrics that incorporate continuous improvement methodologies

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • The incumbent should have a strong technical/Quality background with specific experience in Biologics manufacture. Manufacturing site experience /CMO oversight experience would be valuable. The person will have a thorough knowledge  of GMPs ,Compliance and Quality Systems.

Leadership

  • This person will work in collaboration with Global Quality Systems and Compliance ,the CMOs, Takeda CMO/CTL teams ,Quality teams and cross functionally with external supply, planning , technical and other stakeholders .

  • Good communication and interpersonal skills are required.

  • Demonstrates Takeda values in role.

Decision-making and Autonomy

  • Preparation and initiator approval of Quality Systems and Compliance documents 

Interaction

  • This person will work in collaboration with the Quality teams and cross functionally with external supply, planning , technical and other stakeholders including CMO/CTL partners .

Innovation

  • The person will lead continuous improvement initiatives in the external team and support continuous improvement initiatives in Biologics external supply

Complexity

  • The scope of this role spans Drug Substance, Drug Product, Finished Drug Product manufactured at multiple CMOs across the region.

What you bring to Takeda:

  • 6 + years’ experience working in manufacturing and/or Quality to support the manufacturing of biologic products.

  • Thorough understanding of quality systems and cGMPs.

  • Experience conducting audits and/or involvement in preparation for Health Authority inspections.

  • Interpersonal skills and communication skills to interact with CMO /CTL partners and other functions.

  • Must be able to prioritize in a busy environment.

  • Must be able to travel -approx 20% (domestic and international).

  • Must be fluent in English.

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.

Locations

IRL - Dublin - Baggot Street

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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