Qualified Person, Cell Therapy - Grange Castle

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Qualified Person, Cell Therapy - Grange Castle

Dublin, Ireland

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Business Area Overview

On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:

  • Small Molecules
  • Biologics
  • Plasma
  • Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Working at Takeda

  • Inclusion

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  • Collaboration

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  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 11 companies to receive Top Global Employer® status for 2022.

  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Empowerment

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

Qualified Person, Cell Therapy - Grange Castle

Job ID R0067162 Date posted May. 12, 2022 Location Dublin, Ireland

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Job Description

About the role:

The Qualified Person (Cell Therapy) is a key member of the Quality Assurance team associated with sterile manufacture of Alofisel, a Cell Therapy product at Takeda Ireland Limited Grange Castle (TILGC).   

In particular, the Qualified Person will assume the role of Qualified Person for the release of Alofisel in accordance with EU Directive 2001/83/EC.

In accordance with business needs, the Qualified Person may assume responsibilities in any work area of the TILGC Quality Department, Cell Therapy.

As with all site personnel, the Qualified Person is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Cell Therapy Quality Department and across the Takeda Grange Castle site.

Fully onsite work mode.

How you will contribute:

The responsibilities of the Qualified Person include the following:

  • Management of batch disposition and material status control activities associated with Cell Therapy Products acting as a Qualified Person.

  • Management of review of Batch Manufacturing Records (BMRs).

  • Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.

  • Management of the Change Control process associated with Cell Therapy manufacture and testing, ensuring controlled implementation of all GMP changes.

  • QA oversight of routine manufacturing, testing and relating activities to ensure on-going cGMP compliance.

  • Ensuring effective participation of the Quality Assurance team in production and other site meetings.

  • Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.

  • Participation in the site Internal Audit programme.

  • Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.

  • Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.

  • Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement. 

  • Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.

  • Communication and liaison with other TILGC departments on Quality issues (as required), providing guidance and support to others.

  • Acting as a designee to the Head of Quality(Operations) as required.

  • Participate fully in any cross functional training initiatives.

  • Drive and promote the corporate values of Takeda-ism within the workplace.

  • Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.

  • Ensure timely completion of all SOP reading, training and assessment.

What you bring to Takeda:

  • Primary Degree in a scientific discipline

  • Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC.

  • Minimum of 5 years’ experience in the pharmaceutical industry in a Quality role.

  • Experience of sterile manufacture is essential.

  • Experience of biologics manufacture is desirable. 

  • Excellent knowledge of Good Manufacturing Practice for Advanced Therapeutic Medical Product (ATPM).

  • High level of initiative.

  • Excellent verbal and written communication skills.

  • Strong project management and organisational skills.

  • Ability to adapt to changing priorities.

What Takeda can offer you:

Full Healthcare Cover - includes dependents

Pension Scheme

Attractive Bonus

Subsidised canteen

Parking facilities with electric car charging points

Health & Wellness programs including onsite flu shots and health screenings

Educational Assistance

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

  • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

  • Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

  • Work in a cold, wet environment.

  • Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

  • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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  • Unleash the power of data and digital

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