Quality Assurance SupervisorReq # JR - 012232 Location Lessines, Wallonia, Belgium Job Category Quality Control Date posted 12/27/2019
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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Manage and control finished product release activities (drugs and medical devices),
Be the plant contact person for Advanced Surgery Medical Devices released by Lessines site,
Project management (continuous improvement).
Essential Duties and Responsibilities
- To be responsible for the coordination and planning of batch file review activities of the release team (<10 persons).
- Monitor and improve the performance of the Release department.
- Assure establishing all regulatory aspects (documentation and procedure updates, quality agreements, …).
Advanced Surgery (product released by Lessines site)
- Coordinate labeling changes, implementation, obsoletion as well as BOM updates with CMOs.
- Own specifications (creation, change/update and obsoletion) in Baxter documentation systems
- Write tests validation protocols, coordinating and executing tasks and writing protocol reports (for Medical devices released by Lessines).
- Coordinate/support Supplier notification of change and supplier corrective action request.
- Product complaints: support the local complaint coordinator with complaint investigation and deviation, as applicable for medical devices.
- Assure escalation of any potential issues and field action and gather data to assist field action process (in area of responsibility).
- Facilitate interactions between Baxter and CMO/3rd party suppliers (including services)
- Support external and internal audits when Medical Devices are in scope.
- Ensure appropriate linkage with Advanced Surgery stakeholders (e.g.; RA, PDO, QA, labeling team).
- Support in assuring the conformity of the Lessines plant to the Medical Devices regulation and applicable ISO standards.
- Responsible for KPI (Key Performance Indicators) to be submitted to the Region/Global for the processes in area of responsibility for medical devises.
Project management (continuous improvement)
- Lead, participate to the realization or coordination of Release and Advanced Surgery projects.
- Participate in quality training development and deliver quality training like GMP.
- Participate in the EMS/6S implementation and continuous improvement.
- Minimum Bachelor degree in science or equivalent acquired through relevant experience.
- 3 to 5 years of experience
- Communication skills
- Dedication to Quality
- Excellent knowledge Quality Systems requirements
- Project Management skills
- Knowledge of GMP (Eudralex Vol. 4) and Medical Devices directive, ISO13485
- Pharmaceutical, drugs and Medical Devices environment, deep knowledge on Quality Systems and compliance. Experience on project management
- Is very well organized, has analytical and critical mind.
- Good communication skills and experience in people management : interact efficiently with team members and all stakeholders, effective communication
- Team spirit minded.
- Dedicated to Quality
- Accountable and integer
- Dynamic and motivated
- Fluent in English and French
- Stakeholder and results orientated
- Ability to work in a changing environment
- Good interpersonal skills
- Project Management knowledge
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.