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MI&S - Analytical Method SME I

Lessines, Belgium

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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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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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MI&S - Analytical Method SME I

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Job ID SR0050283 Date posted 06/18/2020 Location Lessines, Belgium

Your responsibilities:

Assure GMP compliant and timely method implementation and method maintenance

  • Plan and document method validation activities together with QC lab
  • Manage activities to support key projects: e.g. assay transfers
  • Create and review submission documents: e.g. consolidated validation reports, justification of Specification
  • Assure implementation of assay controls and qualification of critical reagents

Identify, lead and drive improvements or remediation for analytical assays

  • Support new method development
  • Conduct trendings (e.g. Control trending)
  • Support or lead analytical assay investigations or problems solving (OOS, CAPA, invalids, etc)
  • Drive assays improvement

Support audits: assure inspection readiness, act as SME if required (e.g. presentation of SOP, DP or validation documents …) Change owner

  • Plan and document change requests related to analytical methods
  • Implement change requests in a timely manner
  • Work with Regulatory Department (RA), Product Quality Lead (PQL) and Chemical Manufacturing Control (CMC) Leads for submissions
  • Within the frame of changes submission, provide answers to MoH authorities

Local SME for QC related divisional procedures: support Global QC initiatives Back-up of QC MI&S site Lead

Your profile:

Master’s degree in science (Biological, Chemical, Biochemical, …) or equivalent with minimum 3 years of experience in a similar function. Experienced with analytical methods and method validation, preferentially within a GMP QC laboratory

1.         Knowledge

  • Experience with GMP/GDP requirements
  • Knowledge in analytical methods (Biology, microbiology, immunology, serology)
  • Knowledge in analytical method validation and critical reagent qualification
  • Good statistical knowledge and experience with data analysis
  • Knowledge about regulatory requirements concerning analytical methods
  • Experience with problem solving tools

2.         Skills

  • Target-oriented
  • Team player
  • Strong communication and organizational skills
  • Autonomy
  • Analytical thinking
  • Problem solving skills
  • Technical writing skills (in English)
  • Fluent in French and English

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 SR0050283

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