Skip to main content

Search Our Jobs

Search with LinkedIn Profile

Quality Specialist Disposition

Dublin, Ireland

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.

Back to Job Navigation (Overview)

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
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

Back to Job Navigation (Success)

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.

Back to Job Navigation (Rewards)

Quality Specialist Disposition

Apply Now
Job ID SR0039027 Date posted 09/09/2019 Location Dublin, Ireland

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our Quality Specialist – Disposition.

Our Disposition team is accountable for batch disposition for Biologics product manufactured at CMOs on behalf of Takeda.

The scope includes Drug Substance, Drug product and Finished Drug Product

The Disposition team will work with our external CMO partners and internal Quality teams. In addition, this function works closely with External Supply, Supply Planning, Technical support and any stakeholders involved in external supply.

Key Accountabilities

  • Reviewing batch documentation, data, certificates of analyses, technical reports and providing support to Quality Disposition personnel
  • Evaluating, designing and implementing quality systems relating to batch disposition  
  • Maintaining and improving quality metrics that incorporate continuous improvement methodologies
  • Facilitating, approving and providing inputs into deviation investigations, change controls, CAPA, investigations and nonconformance reviews as required
  • Supporting batch disposition processes as required person will work in collaboration with the Disposition team, Quality teams and cross functionally with external supply, planning, technical and other stakeholders including CMO partners to disposition batches.
  • Evaluation of CMO’s Quality Management Systems to ensure appropriate level and content of reporting, including technical evaluation of quality system reports
  • Evaluation of batch manufacturing records to determine assurances of safety, identity, strength, quality, or purity
  • Determining impact of production / release schedule changes to commercial supply
  • On-going evaluation of Takeda’s batch review / release systems to ensure efficient and effective processes are implemented with integrated continuous improvement methodologies
  • You will lead continuous improvement initiatives in the batch disposition team and support continuous improvement initiatives in Biologics external supply
  • The scope of this role spans Drug Substance, Drug Product, Finished Drug Product manufactured at multiple CMOs across the region

Key skills required

  • Thorough understanding of quality systems and cGMPs.
  • Manufacturing site experience would be valuable.
  • Experience conducting audits and/or involvement in preparation for Health Authority inspections.

Education, Behavioural Competencies  

  • 6 years’ + experience working in manufacturing and/or Quality to support the manufacturing of biologic products.
  • Strong technical/Quality background with specific experience in Biologics manufacture. Manufacturing site experience would be valuable.
  • Interpersonal skills and communication skills to interact with CMO partners and other functions.
  • Must be able to prioritize in a busy environment.
  • Must be available to travel -approx 20% (domestic and international)

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.



Job ID SR0039027

Apply Now Email Me

Explore the Area

Check out where you could be
working if you apply.

View Map