Quality Assurance Supervisor
For a global market leader in the field where medical devices meet pharmaceuticals, we are looking for a Quality Assurance Supervisor, working in the production site in Belgium. She/he leads a release team, responsible for the coordination and planning of batch file review activities.
- Manage and control finished product release activities (drugs and medical devices),
- Be the plant contact person for Advanced Surgery Medical Devices,
- 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,…)
Advanced Surgery (product release by plant)
- Coordinate labeling changes, implementation, obsoletion as well as BOM updates with CMOs.
- Own specifications (creation, change/update and obsoletion) in the company’s documentation systems
- Write tests validation protocols, coordinating and executing tasks and writing protocol reports.
- 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 the company 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 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 with release in a production environment
- At least a first experience in people management
- Fluent in English and French
- Reside in Belgium
- Dedication to Quality
- Excellent knowledge Quality Systems requirements
- Strong 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
- Very well organized, 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.
- Dynamic and motivated
- Stakeholder and results orientated
- Ability to work in a changing environment
- Good interpersonal skills
Belgium Pharmaceuticals Employee
Belgium Pharmaceuticals Employee
Belgium Medical Devices Employee