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Quality Operations System specialist

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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Quality Operations System specialist

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Job ID SR0043540 Date posted 11/07/2019 Location Lessines, Belgium

Primary Duties

  • Represent the quality function for Change Control:
  • Act as a Quality Representative to review, approve Change Request.
  • Participate to FMEA if requested
  • Redact shut down protocol and approve restart of activities.
  • Represent the quality function for deviations managment:
  • Act as Quality Representative to evaluate, investigate and approve deviations report.
  • Act as a quality link on the floor to support adequate quality systems deployment.
  • Support any quality decision in coordination with systems owner. Provide support and expertise in all quality related issues.
  • Perform GMP walkthroughs during routine operations to ensure the application of the cGxP’s, the compliance to the procedures, and all the aspects linked to the safety, the reliability and the consistency of the operations.
  • Participate to continuous improvement projects (Blue belt, DMAIC, …).
  • Data and trends analysis
  • Provide support for external audits.

Responsibilities

Change Control/Projects/Shut down

Deviations

Continuous improvement

On the floor

Data analysis

Profile

  • Master degree in Science  or Engineering or equivalent with experience
  • 4 - 5 years in pharmaceutical environment , good knowledge on technical equipement used in pharmaceutical industries.

Key skills

  • Good level of reading/writing English
  • Knowing the applicable regulation
  • Critical thinking and probem Solving
  • Organizational skills
  • Collaboration and Teamwork
  • Flexibility
  • Data and trends analysis

Complexity and problem solving

  • Pursuing deep fundamental root cause
  • Schematic and methodic structure
  • Understanding and systematic description of relevant and non-relevant

Other job requirements
  • Persistent curiosity
  • Asking why
  • Pursuing deep fundamental root cause
  • Schematic and methodic structure
  • Confident to communicate

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 SR0043540

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