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Engineering Change Management Coordinator

Lessines, Belgium

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Engineering Change Management Coordinator

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Job ID SR0048795 Date posted 07/23/2020 Location Lessines, Belgium

Integrated in the Engineering Services department and within the scope of technical activities, the engineering change coordinator handles change requests on critical equipment and processes. Together with technical experts, a Quality and Regulatory representative, the engineering change coordinator is responsible for gathering appropriate information on the change to be implemented in order to assure a correct and structured impact assessment and change plan, documented in the TrackWise System. He/she establishes an effective communication between the involved experts and makes sure that the change proceeds in a timely manner.

ACCOUNTABILITIES

  • Collects information relative to the to be implemented change near the involved departments
  • Writes the documentation relative to the change request in a structured, rigorous and detailed manner
  • Performs a complete quality assessment together with the Quality department
  • Assures that an adequate regulatory assessment is made
  • Defines the change plan and sequences the tasks needed to accomplish the change request
  • Works with the functional leads to schedules people and resources for each task
  • Encodes all the information related to the change request in the TrackWise system
  • Provides status updates to management
  • Reviews all completed taks before implementation
  • Coodinates the change requests with respect to targets
  • Develops and maintains an effective communication with the expert departments (Quality, Regulatory Affairs, Engineering, Maintenance, Metrology, Environmental Monitoring, Production, Validation)
  • Assures a supportive role during audits

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Master in Engineering or Science or Quality
  • 2-3 years of experience in a pharmaceutical environment
  • Effective communication
  • Organised, stuctured, rigorous
  • Good writing skills in English
  • Focus on the overall picture
  • Excellent knowledge of MS Office
  • Good French and English knowledge
  • Stress resistant
  • Knowledge of quality regulations (GMP, GDP, FDA, Eudralex)

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 SR0048795

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