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We are searching for the best talent for Qualification Engineer - Facilities & Utilities to be in Gent and Beerse, Belgium

You will be responsible for: :

• Will work closely together with the 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 facilities & utilities with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented
• Will work closely together with Engineering & Property Service 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
• Will build a strong connect with different quality organizations
• 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 reviews
• Participates in the preparation for regulatory and customer inspections and act as a spokesperson for QA qualification
• Approves 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.
• Participates 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.

Qualifications & Requirements:

• master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences
• awareness 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 our strategy and documents towards health authority inspections.
• affinity with computerized systems, System parameter configurations and data management in critical production assets
• ability to show and apply strong communication skills and are known as a great teammate who can work cross departmental in a continuous changing environment
• thorough knowledge of Dutch and English, both orally and in writing
• Strong analytical thinking, risk assessment and communication skills
• Collaboration and teaming skills

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