Quality Assurance Specialist

il y a 13 heures


Brussels, Belgique Vivid Resourcing Temps plein

Job Title: Quality EngineerLocation: BrusselsRole Type: Onsite/HybridSalary: Up To €70,000Overview:The Quality Engineer ensures the qualification and maintenance of manufacturing equipment, utilities, facilities, and automated systems, guaranteeing compliance with regulatory standards and maintaining a state of validated operations.Key Responsibilities:Execute, plan, coordinate, and follow up on qualification and validation activities for equipment, systems, and facilities (e.g., HVAC, QC equipment, automation).Develop, write, and implement qualification-related SOPs, protocols, work instructions, templates, and tools.Maintain the qualified status of equipment through periodic review, change control, and requalification.Support harmonization of qualification strategies and processes.Stay up-to-date with international regulations and guidelines (e.g., cGMP, Part 11, ISO 13485, 21 CFR 820) and apply knowledge to improve qualification practices.Serve as a spokesperson during internal and external audits regarding equipment and system qualification.Requirements:Master's degree in engineering, pharmacy, or equivalent experience.3+ years in pharmaceuticals, medical devices, diagnostics, or highly regulated manufacturing.Strong technical writing and documentation skills.Analytical, process-oriented, and self-organized with technical understanding of manufacturing assets.Experience with diagnostic/IVD manufacturing, regulatory audits (FDA, FAGG), and qualification/validation standards is a plus.Proficiency in MS Office and ability to adapt, communicate clearly, and work under pressure.


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