Job Description

• Collaborate closely with the MAM (Make Asset Management) and E&PS department to 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. 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.
• Work closely 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.
• Build a strong connection with different quality organizations.
• Manage the compliance status of critical production (make) assets by reviewing and approving procedures such as calibration rationales, calibration master forms, completed calibration records, master data set-up, maintenance plans, and following up on daily operations activities by reviewing and approving data integrity deliverables such as system audit trail and user access reviews.
• Approve qualification documents (change controls, master documents, protocols, reports, rationales, SOPs, URS, IA, QSR, etc.), including discrepancies/events/non-conforming situations and related corrective actions (correction, CPA) occurring during the execution of qualification activities.
• Participate in system and process improvement/optimization projects, ensuring quality and compliance aspects are maintained, and keep current knowledge of international regulations, guidelines, and industry practices to become the QA process expert.

About the Candidate

The candidate should have the following proficiencies:

• Master’s degree in engineering with a chemistry or analytical background or in pharmaceutical sciences.
• Awareness of quality; knowledge of cGMP regulations and FDA/EU guidance related to the manufacturing of cell therapy products and sees it as a challenge to defend our strategy and documents during 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 is known as a great teammate who can work cross-departmentally in a continuously 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.

The client is located in Ghent, Belgium