in V&V for medical devices Hands-on experience in: o Protocol writing (IQ, OQ, PQ, CSV, system validation) o Validation execution...
creation and improving of Operations documentation. Lead process validation (IQ/OQ/PQ), PFMEA, and risk management to ensure...
and qualification activities (FAT, SAT, IQ/OQ/PQ where applicable). Manage and track system deliverables in line with project schedule...
, and review validation protocols (DQ, IQ, OQ, PQ) for new and modified equipment, processes, and systems. Peer review/approve...
) functions as required;schedule deliveries with transporters or generators Utilize SAP and WFMS for PQ set up, material...
Regulatory expectations Support execution and review of: IQ/OQ/PQ protocols Engineering test runs Risk assessments...
and qualification activities (FAT, SAT, IQ/OQ/PQ where applicable). Manage and track system deliverables in line with project schedule...
and qualification activities (FAT, SAT, IQ/OQ/PQ where applicable). Manage and track system deliverables in line with project schedule...
Experience with process validation (IQ/OQ/PQ), PFMEA, control plans, and statistical process control (SPC) WHAT YOU’LL GAIN...
Process and Cleaning Validation Experience Equipment Qualification (IOQ/PQ) Quality System Experience (Veeva, Trackwise...