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Labelling Project Lead

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Other
  • Date posted: 07/02/2018
  • Job reference: J381258A

Labelling Project Lead

Labelling Project Lead required to join a leading medical device manufacturing company in Waterford to support an exciting ramp-up onsite. The Labelling Project Lead will be responsible for managing the labelling strategy, changes and activities for the global implementation of the MDR.

Responsibilities:

  • Develop Packaging/Artwork/Labelling requirements for all contact lens sites within scope of the project.
  • Create a strategy for the implementation of MDR requirements.
  • Liaise with cross functional teams on the strategy.
  • Communicate with stakeholders ensuring acceptance of labelling changes in regions outside EU who accept CE marked product.
  • Project management of the packaging/artwork/labelling deliverables.
  • Perform gap assessment against the required standards for the labelling portfolio for contact lens.
  • Remediate gaps for labelling for contact lens.
  • Work with cross functional site teams on the implementation of labelling requirements for all products within scope.
  • On time delivery of the schedule.
  • Change management activities for the implementation of MDR labelling requirements.
  • Other duties as assigned by manager

Qualifications/Experience:

  • Third level Qualification in Science or Engineering
  • Knowledge of labelling/packaging regulations
  • Previous experience of implementing labelling/packaging changes
  • New product introduction (is an advantage)
  • Cross functional project team management
  • Working Knowledge of MS project
  • Working knowledge of change management systems/processes.
  • Experience project manager
  • Working knowledge of packaging and labelling processes
  • Working knowledge of global QMS systems (e.g. Kintana, D2, ELM)
  • Decisive, self-motivated
  • Medical Device or Pharmaceutical experience
  • Good communication skills (verbal & written)
  • cGMP

For more information contact Paul on 01 6455250 or email paul.oconnorATexperis.ie

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