2 dagen geleden

Company :

Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.

As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

Activities :

You will act as Labeling Project Leader for the Baxter Geo-Expansion project (planned product launches to new countries), for label changes related to products manufactured in region EMEA manufacturing sites.

As part of your role, you will :

  • You will act as the central point of contact for all labeling changes related to Baxter Geo-Expansion project. As part of this, you will :
  • Analyze labeling impact for each single country (no labeling, create country specific labeling or relabeling, update existing labeling)
  • Ensure with the Labeling Project Leaders (supporting specific Manufacturing Sites) the launch gets correctly prioritized.
  • Follow up status update and implementation and provide report to Geo-Expansion Core Team.

  • Where needed, drive labeling change from initiation to implementation on the product :
  • Be responsible for owning and managing multiple labeling change control projects.
  • Organize and facilitate label change control project updates and approval meetings, as appropriate
  • Perform accurate product and project data entries in a change control management system.
  • Collect and consolidate information required to initiate change controls related to label changes
  • Liaise with the Subject Matter Experts from the different functions (Regulatory, Labeling Center, Manufacturing, R&D, Quality )
  • Coordinate project documentation
  • Create and maintain project schedules, assist in tracking team deliverables for project completion
  • You will ensure that processes and procedures related to labeling activities, including change controls, are compliant to local Regulations, to the Corporate Quality Manual, ISO 9001 / 13485 requirements and to Regional and Corporate procedures
  • You will support labeling team project initiatives
  • You will support audit and inspection program, support and expertise for CAPA related to labeling, ensure records are maintained and trainings delivered when required.
  • Who you are : You have :

    You have :

  • A master degree in life-science or engineering and 1 to 3 years industry experience in Pharmaceutical or Medical device related industry.
  • An excellent level of English (Spoken, Read, Written)
  • Knowledge of ISO9001 or ISO13485 requirements
  • Knowledge of Word, Excel, Powerpoint and Microsoft Office
  • Good project management skills
  • Quality System processes knowledge and experience (experience in change control is a plus)
  • A pragmatic approach, hands-on attitude
  • Strong analytical / problem solving skills
  • Excellent team-work and collaboration skills
  • Strong communication skills : needs to cascade information both ways and ensure consistent, concise, clear messages to all, influence others skills
  • Positive approach, optimism
  • You are :

  • Results oriented with a process and quality driven approach
  • Self-driven with the ability to work independently as needed
  • Critical thinking and you have the ability to challenge the status quo
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