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Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
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  • Enthusiastic
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Opportunity

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

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

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

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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

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QP CMO

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Job ID R0012091 Date posted 09/12/2019 Location Dublin, Ireland

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Job Description

JOB PURPOSE:

The Qualified Person is a key member of the Quality Assurance team associated with QP Certification of drug product at Takeda Ireland Limited Grange Castle (TILGC).   

In particular, the Qualified Person will assume the role of Qualified Person for the release of drug product 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.

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

RESPONSIBILITIES:

The responsibilities of the Qualified Person include the following:

  • Quality oversight of contract manufacturers, testing and for leading, monitoring and supporting the quality performance of quality systems according to GMP standards which consists of, but not limited to, change controls, deviations, CAPAs, complaints, documentation and material supplier management.
  • Ensuring effective participation as the Quality Assurance representative in Material Review Boards, CMO Quality Reviews and Supply planning
  • Management of batch disposition of drug product; site CMO Qualified Person
  • Management of review of CMO Batch Manufacturing Records (BMRs).
  • Generation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
  • Participation in the Global Audit programme of CMOs.
  • 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 Takeda sites on Quality issues (as required), providing guidance and support to others.

Supervisory duties for Quality Assurance personnel may be part of the role

GENERAL RESPONSIBILITIES:

  • 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.
  • Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.

EDUCATIONAL REQUIREMENTS: 

  • Primary Degree in a scientific discipline
  • Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC

RELEVANT EXPERIENCE:

  • Minimum of 5 years’ experience in the pharmaceutical industry in a Quality role.
  • Experience of oral solid dosage manufacture.

SKILLS / COMPETENCIES:

  • Excellent knowledge of Good Manufacturing Practice as described in current FDA & EMEA regulations for oral solid dosage pharmaceutical manufacture.
  • High level of initiative.
  • Excellent verbal and written communication skills.
  • Strong project management and organisational skills.
  • Ability to adapt to changing priorities.
  • Qualified Person status is essential

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0012091

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