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MI&S - Analytical Method SME I

Lessines, Belgium


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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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