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LE Quality Validation Eng II

Lessines, Belgium


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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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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  • 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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LE Quality Validation Eng II

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Job ID SR0037086 Date posted 11/19/2019 Location Lessines, Belgium

  • Review/approval of validation documentation, specification documents (URS, Functional/ Design Specification) and study protocols/ reports (IQ/ OQ/ PQ/ PPQ) to ensure compliance to procedures and regulatory requirements.
  • Review and approve test incident occurred during the validation in a quality perspective
  • Participate and approve the risk analysis linked to validation activities in a quality perspective.
  • Review/approval of periodic review of critical system to ensure compliance to procedures and regulatory requirements.
  • Collaboration and participations in projects as Quality Representative for Validation. Provide quality guidance for the development of the validation approach. Assure requirements traceability throughout the whole project validation file (from URS to PQ).
  • Take part in internal and external audits.
  • Affinity/Experience with Computerized Systems Validation (CSV) and Data Integrity, as well as Process or Equipment Validation.
  • Skills : Computerized System minded.

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 SR0037086

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