Cristina Neira

Experience

• 

  ACIST Medical System Inc. (Bracco Group)

  Mar 2012 - Jul 2013

  Project Manager presso il gruppo Sustaining Engineering

  - Management of Verification and Validation activities for new medical devices- Validation of Secondary packaging (ASTM D4169-09)- Management of the activities for creating/updating labels, manuals and leaflets- Management of biocompatibility testing on medical devices (ISO 10993-1: 2009)- Change Order writing

• 

  Bracco

  Nov 2014 - now

  -Define project objectives, scope, deliverables and communicate them to the team-Create high-level project documentations like project charter and project plan-Develop project schedule to help tasks prioritization and track deliverables.-Define project milestone and metrics-Interact with stakeholders, suppliers, CMO and support cross-functional collaboration and project execution-Monitor and report on project progress-Present to stakeholders reports on progress, problems and solutions-Implement and manage change when necessary to meet project outputs Show less - Project management - Packaging and medical device innovation, troubleshooting and test planning- Summary report writing/review and results presentation- Consultation of Pharmacopoeia (EP/USP) and main standards related to medical devices and pharmaceutical packaging- Guarantee technical support to corporate functions (TO, CQM, Marketing, Regulatory Affairs etc..)- Guarantee the technical efficiency of laboratories and equipment in terms of validation status and of health and safety procedures- Support the department manager in the planning and management activities and in the definition of budget and investments Show less

  • Project Manager

    Feb 2022 - now

  • Lab manager

    Nov 2014 - Jan 2022