Responsibilities:

  • Perform C&Q in accordance with GFD procedures, best practices, specifications, and project planning documents.
  • Preparation of documents associated with C&Q activities.
  • Preparation and execution of FAT, and SAT protocols
  • Review equipment specifications to ensure FAT, SAT and PIM requirements are included, as appropriate.
  • Design Qualification (DQ) protocol preparation, execution, and follow-up
  • Preparation and execution of Qualification protocols (IQ,OQ, PQ)
  • Field Walkdowns of systems as part of transfer of ownership of the system from Construction
  • Ensuring safe operation of the system prior to and during start-up functional testing and Qualification phases
  • Nonconformity management during project lifecycle
  • Summary Report writing
  • Organize and review daily tasks/verifications and track the progress of the activities assigned.
  • Contractors and/or Vendors coordination
  • Interfacing with representatives on project team, Construction, Engineering, Automation, Quality and End Users during the different project phases.
  • Collaborate with Automation contractors in support of integrated C&Q/CSV approach.
  • Provide weekly status updates to C&Q Material Preparation Lead

Candidate requirements :

  • BS Engineering (or equivalent experience)
  • 5 years working in pharmaceutical environment and if possible, in sterile process.
  • Minimum 5 years C&Q experience
  • One significant experience in Qualification of Autoclave, Washer or Component processor
  • Good knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification.
  • One significant experience in Commissioning & Qualification of Isolators packages
  • Good written and verbal communication skills with both technical and non-technical staff (French+English)
  • KNEAT knowledge is a plus for the position.
Job Overview
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