• Freelance
  • Meppel
  • 7 maanden geleden geplaatst
  • Solliciteren is gesloten

IMBRI

The Memphis project has the assignment to roll out a Manufacturing Execution System over seven sites. After the initiation phase the project is full steam ahead, trying to make the challenging milestones.

The program is split up in three project team, which is responsible for the implementation of the MES solution on site. The three teams work in parallel, each focusing on a specific site, managed and supported from a core team.

For one the focus teams we are looking for an experienced Test Coordinator / Validation team lead, who can manage all test activities related to the roll out on the target site. A clear Validation Strategy is layed down in an overall Validation Plan, which is the guide for the Test Coordinator to create a site specific Plan of Approach and execute this plan in relation to a very challenging schedule.

The Test Coordinator / Validation team lead we are looking for is someone with multiple years’ experience in a regulated environment (Food / Pharma), with good understanding of good validation and testing practices of computer software application. Besides validation experience we also like to see experience in coordinating testing teams (key user / SME). We like you take control over the entire test and validation phase, based on the strategy and lead the testing team. You have to be a pioneer, not everything is already described, scheduled or worked out. Also work within the boundaries of the strategy and site specific timelines.

Because of a strict schedule having demanding and challenging deadline, we don’t always follow the 9-5 working days.

 

Key activities

  • Create detailed Validation / Test Plan of Approach for target site
  • Create schedule having test activities against timelines, resource schedule showing workload etc.
  • Manage preparation and execution of all tests involved
  • Manage defects / deviations and retesting

 

Skills

  • Team player
  • Team lead
  • Good eye for the contradiction between quality and deadlines
  • Knowledge of
    • T-MAP
      • Test types
      • Test technics
      • Reporting
    • GAMP5
    • GxP
    • Prince 2 foundation

 

  • Experience
    • Validation of software application, preferably MES in regulated environment
    • GAMP5, Risk Based Validation

 

It’s a challenging role in a great project, full of opportunities. Are you the one we want for this job?