Duration: 5-day assessment, plus preparation, report writing and compliance recommendations/planTitle: GMP Compliance Gap AssessmentDescription: The client is looking for an experienced GMP compliance consultant with expertise in sterile/aseptic manufacturing operations to perform an on-site assessment of compliance with EU Annex 1 for AIFA pre-inspection purposes for the Multipurpose 3B department for sterile aseptic production of liquid and lyophilized drugs in vials, both Non-HP and HP, in isolator technology (approximately 2500 sqm), consisting of:A separate building department equipped with dedicated HVAC and N2, dedicated WFI loop and storage (common production), dedicated AC distribution, CS from an existing department.Grade D areas (e.g., changing rooms, A/Ls, transit corridors, general department storage areas, secondary packaging (tray loading), control room).Grade C areas (e.g., changing rooms, A/Ls, transit corridors, Non-HP compounding, HP compounding, washing area, clean and autoclaved material storage area, filling and lyophilization area, IPC room, cold room).Filling line consisting of an internal/external vial washer, depyrogenation tunnel, filling station, two freeze dryers each with an automatic loading/unloading system, crimping machine, external vial washer, all under a Grade A isolator (except for the external vial washer; 3 units).Sampling isolator, dispensing isolator, bagging oRAB for stoppers, passbox, material transfer isolator, non-pass-through autoclave, parts washer.Please note that the assessment must also evaluate the correctness and completeness of the procedural framework, gowning, validation, monitoring, media fill, and, more generally, all aspects impacting compliance as outlined in the reference standard (Annex 1).Seniority levelMid-Senior levelEmployment typeContractJob functionConsultingIndustriesPharmaceutical Manufacturing and Medical Equipment Manufacturing
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