and process validation principles (IQ, OQ, PQ) and their application in regulated manufacturing environments Experience hosting...
for AI-driven decision-making systems. Author and review validation documentation (URS, FS, DS, IQ/OQ/PQ protocols, reports...
preventive and unscheduled maintenance activities on their equipment within their assigned work center. Support IQ, OQ, and PQ...
results from 1st article and Process validations (IQ-OQ-PQ) studies during product launch and subsequent changes to tooling... process, such as process improvement, problem-solving, AQL Levels, FMEA, validations (IQ/OQ/PQ), DOE, and metrics. Provide...
with PowerShell scripting for automation and validation tasks. ⦠Experience in software validation methodologies, including IQ/OQ/PQ...
execution with suppliers and ensure robust process qualification/validation using IQ, OQ, and PQ methodologies. Define.... Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans. Familiarity with FDA and ISO 13485 standards. Excellent...
including EO parametric requirements, DEO, SLR and cycle calculations. Lead and execute validation activities (IQ, OQ, PQ...
, installation, and IQ/OQ/PQ of new instruments and equipment. Work with other team members to manage the OpenLab chromatography...
: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment. Aim... (Operational Qualification), and PQ (Performance Qualification) protocols and reports. Proficiency in developing and executing IQ...
and protocols (IQ, OQ, TMV, PQ) and other deliverables for equipment qualification and requalification. Make independent decisions...