PROJECT LEADER - LABELING OPERATIONS HF

Job description

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:
- 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