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Project Leader

  1. Brussels
Brussels
  1. Contract
Competitive
  1. CAPEX Projects, Commissioning, Qualification and Validation
19-03-2021
26483/AN

This vacancy has now expired

Project Leader (Validation) - 9 month Contract - Brussels

Excellent freelance opportunity for a senior consultant to support a cell and gene therapy company on their latest investment in the south of Brussels.

The ideal candidate will possess:
  • 10-15 years’ experience in a senior validation role
  • Facility Start Up experience and ensure oversight of the qualification (IQ, OQ, PQ) and validation (PPQ, CV, PV) activities. 
  • Strong knowledge of biotech industry and processes (Need cleanrooms experience)
  • Responsible for writing, reviewing and approving validation documents (Risk Assessment, PQ Protocol, PQ Report,…).
  • Fluent French 
As the Validation Project Lead you will be responsible for:
  • Establishing the Validation Plan and be accountable for all cGMP decisions taken during the Validation of the project starting with the Design Qualification step and ending with the establishment of the Validation Summary report.
  • Responsible for the implementation of the validation guideline and SOP for the processes & equipment (Validation life-cycle process, Qualifications, Process Validation).
  • Responsible for the implementation of adequate validation strategy in compliance with FDA, EMEA and International quality standards.
  • Responsible for assuring inspection readiness – regarding Validation
  • Responsible for smooth handover from PPQ/Process Validation to production (Training, SOPs etc.)
If you are interested in working in this revolutionary new market and you have the right background and experience for this role, please apply now!

The candidate must have the rights to work in the location stated in the job advert.

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