Thermo Fisher Scientific

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Originele vacaturetekst

Supervisor Quality on the Floor

Key Areas of accountability/responsibility

The job of Supervisor Quality on the Floor will include a selection of the responsibilities mentioned below:

  • Responsible for the coordination of the Quality on the floor: direct engagement, real time, of Quality professionals with manufacturing shop floor operations including cGMP guidance, document review and approval, deviation handling and advice regarding documentation quality practices.
  • Assign department’s resources to new and existing projects, apply workload leveling, and assure proper training of resources within the department.
  • Advise to project organization and customers on all relevant cGMP matters and assure appropriate cGMP level of project activities.
  • Practical application of various risk assessment tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies) and the ability to directly develop, participate and advise others on the appropriate and efficient application of these processes.
  • Understanding of the connection between floor documentation and the batch disposition process.
  • Advise, facilitate, and support all phases of manufacturing batch documentation development including, but not limited to the initiation, authoring, approval and mastering.
  • Quality review and approval of cGMP documentation.
  • Act as a mentor/coach of the Quality systems applicable (Batch record review, deviations, change requests, annual product review)
  • Alignment of Standard Operating Procedures, documentation practices, laboratory testing, and efficient documentation flows in the Quality release of raw materials, buffers/media and area/equipment.
  • Use, scope, development and orchestration of incident investigations toward the goals of both adequately understanding root cause (including causality vs correlation) and avoiding repeated incidence (corrective action, preventative action and effectiveness verification). Handling of deviations.
  • Application of cGMP change control

Required Level of Experiences

  • Minimum of 5 years relevant experience in a (bio) pharmaceutical company.
  • Excellent knowledge of pharmaceutical cGMP systems and international cGMP regulations and guidelines.
  • Experience on managing a group of people.
  • Experience with project management.

Competences

  • Decisiveness
  • Planning and organizing
  • Problem analysis
  • Initiative
  • Judgment
  • Customer satisfaction
  • Result Oriented
  • Teamwork
  • People management
  • Leadership
Dienstverband:
fulltime, parttime

Vaardigheden

  • Er is geen minimale opleiding vereist

Wat wij bieden

Contract:
Parttime - Fulltime