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.
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