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Material Qualification (MQ) 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

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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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Material Qualification (MQ) Specialist

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Job ID SR0043812 Date posted 11/05/2019 Location Lessines, Belgium

Summary:

The Material Qualification Specialist, part of the Lessines MS (Manufacturing Sciences) organization, is responsible for performing and coordinating activities linked to Material Qualification :

  • Projects within the plant and/or network (e.a. new products/ equipment/ components)
  • Material Lifecycle Management (e.a. changes impacting material qualification, impact evaluation against new requirements)
  • Continuous improvement (e.a. new materials improving product quality, process robustness)
  • Manufacturing deviations (e.a. root cause investigation and product impact evaluation)
  • Regulatory submissions and inspections


Responsibilities:

-  Acts as a material qualification representative for small, mid size and big projects within the plant and/or network :

  • Provides Material Qualification expertise to ensure the success of the project
  • Defines, prepares and implements all Material Qualification activities related to the project (MQ strategy, documentation approach and structure), in accordance to local and global MQ requirements.
  • Participates in the risk assessment and in the other qualification/validation activities related to the project.
  • Prepares and implements Material Qualification documentation, assuring requirements traceability throughout the whole project file (from URS to submission), and the update of the MQ database and documentation.
  • Organizes and coordinates Material Qualification activities with the different involved departments (on the ground, as required) and contractors, in such a way that all of them concur with the committed project milestones.
  • Assures open and honest feedback on status and potential risks/issues, with proposal of mitigation/solution to the Process Sciences and MQ Lead and to the Project lead.

- Closely collaborates with the MQ stakeholders (Process Sciences, Process/Equipment/Cleaning Validation, Production, Quality, Regulatory, Global MQ, …) to ensure the MQ life cycle from process development, validation, submission to routine production.

- Ensures that the Material Qualification status is continuously maintained and improved, following the established local and global MQ strategies.-

- Ensures compliance with current GMP and other regulatory requirements and supports corresponding regulatory submission writing and (oral) defenses during regulatory audits.

- Provides support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.

- Supports or manages deviations and changes in order to guarantee that these are well documented and that corrective/preventative actions are taken and followed-up.

- Assures the ability to meet the Department goals with respect to EHS, Quality, Compliance, Supply and Budget fulfillment.

- Supports the Process Science and MQ team by working on Process Science activities in the context of improvement projects and problem solving (labscale studies,  DMAIC product/process investigations, improvement projects, …)

Profile:

  • BS or Master Degree in Engineering, Chemistry, Life Science, or other job related discipline or equivalent by experience
  • At least 2 years professional experience in Material Qualification or similar role
  • Knowledge of Material Qualification Methodologies, including associated analytical methods and risk assessment tools
  • GMP and bioprocessing knowledge and experience
  • Critical thinking and problem solving (DMAIC) skills
  • Project management experience
  • Excellent verbal and written communication skills (English)
  • Honest and responsible, flexible, customer focused, team player, open minded and out of the box thinker

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 SR0043812

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