Product/Team
For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on.CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system. They are created from the patients' own T-cells and are engineered to eliminate cancer cells expressing a specific antigen.To support the CAR-T program in EMEA, our client started up two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories are operated elsewhere.The CAR-T QA C&Q Engineer is part of the CAR-T QA Qualification Team in Ghent. He/She will be responsible for review and approval of qualification and requalification activities, related to Facilities and Utilities (F&U) and Process Equipment at our client's facilities in Ghent.Job ResponsibilitiesYou will work closely together with the MAM (make asset management) and E&PS department and guard the qualification status of critical production assets by ensuring that all system critical aspects related to facilities & utilities, product and process requirements are identified; qualified and controlled by a mitigation plan and ensure that deviations related to equipment issues with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented.You will work closely together with the manufacturing department to approve new change controls and to ensure that deviations with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented.You will build a strong connect with different quality organizationsYou will manage the compliance status of critical production (make) assets by means of review and approval of procedures e.g. calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans and follow up daily operations activities by review and approval of data integrity deliverables such as system audit trail and user access reviewsYou Participate in the preparation for regulatory and customer inspections and act as a spokesperson for QA qualificationYou approve qualification documents (change controls, master documents, protocols, reports, rationales, SOP's, URS, IA, QSR, etc.) including discrepancies/events/non-conforming situations and related corrective actions (correction, CPA) occurring during execution of qualification activities.You Participate in system and process improvement / optimization projects and assure quality and compliance aspects and maintain a current knowledge of international regulations, guidelines and industry practices and become the QA process expert. xjsrcvqQualificationsmaster's degree in engineering with chemistry or analytical background or in pharmaceutical sciencesawareness of quality; have knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products and you see it as a challenge to defend the strategy and documents towards health authority inspections.affinity with computerized systems, System parameter configurations and data management in critical production assetsability to show and apply strong communication skills and are known as a great teammate who can work cross departmental in a continuous changing environmentthorough knowledge of Dutch and English, both orally and in writingStrong analytical thinking, risk assessment and communication skillsCollaboration and teaming skills