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QA System Senior Professional

Lessines, Belgium

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
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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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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QA System Senior Professional

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Job ID SR0038515 Date posted 08/21/2019 Location Lessines, Belgium

Act as Lessines’ Execution Lead for Quality Systems : Change Control Management System & Deviation Management (GEMS - EUME).

  • Supervise and support the activities related to Quality Systems for the Lessines facility, mainly Change Control Management system,
  • Ensure the deployment and implementation of the global procedures and requirements concerning Quality Systems. 
  • Ensure and maintain compliance with current regulations/requirements of Quality System.
  • Define, review and analyze Quality Systems’ metrics.  Define appropriate actions to maintain satisfactory metrics.
  • Lead Lessines Change Control Board meetings.
  • Participate to the global meetings such as Change Control Expert Council or Exception Management Board.
  • Participate actively to continuous improvement projects related to Quality Systems.
  • Train employees on Quality Systems.  Monitor the Quality systems to ensure compliance with the Global procedures and regulations and evaluate additional need for training/coaching of the users.
  • Coordinate interfacility assesments of upstream and global change requests.
  • Communicate with owners, release, supply chain and any impacted department to ensure disposition of lots impacted by a deviation/investigation or change request.
  • Interact in Annual Report process
  • Support inspections conducted by Health Authorities, Customers and License Partners.

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 SR0038515

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