When you are part of Thermo Fisher Scientific, you will do challenging work, and be part of a team that values performance, quality, and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $35 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Fisher Clinical Services, part of Thermo Fisher Scientific, has an unwavering dedication to service, science and process engineering, Fisher Clinical Services is powered by people with an outstanding dedication to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labelling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards.
5 reasons to work at Thermo Fisher Scientific https://www.youtube.com/watch?v=zPVv85C6XSE
From clinical to commercial production in Groningen, the Netherlands https://www.youtube.com/watch?v=rs2QwTrNCc8
How you will make an impact?
The job of Supervisor Quality on the Floor will include a selection of the responsibilities mentioned below:
Responsible for the coordination of the Quality on the floor: direct engagement, real time, of Quality professionals with manufacturing shop floor operations including cGMP guidance, document review and approval, deviation handling and advice regarding documentation quality practices.
Assign department’s resources to new and existing projects, apply workload leveling, and assure proper training of resources within the department.
Advise to project organization and customers on all relevant cGMP matters and assure appropriate cGMP level of project activities.
Practical application of various risk assessment tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies) and the ability to directly develop, participate and advise others on the appropriate and efficient application of these processes.
Understanding of the connection between floor documentation and the batch disposition process.
Advise, facilitate, and support all phases of manufacturing batch documentation development including, but not limited to the initiation, authoring, approval and mastering.
Quality review and approval of cGMP documentation.
Act as a mentor/coach of the Quality systems applicable (Batch record review, deviations, change requests, annual product review)
Alignment of Standard Operating Procedures, documentation practices, laboratory testing, and efficient documentation flows in the Quality release of raw materials, buffers/media and area/equipment.
Use, scope, development and orchestration of incident investigations toward the goals of both adequately understanding root cause (including causality vs correlation) and avoiding repeated incidence (corrective action, preventative action and effectiveness verification). Handling of deviations.
Application of cGMP change control
Required Level of Experiences
Minimum of 5 years relevant experience in a (bio) pharmaceutical company.
Excellent knowledge of pharmaceutical cGMP systems and international cGMP regulations and guidelines.