and re-validation activities (IQ/OQ/PQ) and continuous improvement projects. Lead and direct sterilization compliance.../PQ). Demonstrated ability to lead and develop quality teams. Excellent written and verbal communication skills...
Validation Plan, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic...
molds using SIM. Perfrom IQ's, OQ' and PQ's. Take part in deveploing PFMEA's and quality documents. Manage technical...
, traceability matrices, and validation reports. Execute IQ/OQ/PQ testing, risk assessments, ALCOA+ evaluations, and change control.../PQ, requirements development, test execution, and traceability. - Familiarity with integrations between MES and ERP...
. Ensure full compliance with GxP documentation standards, including validation activities (IQ, OQ, PQ) and maintaining audit...
, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs...
), and Performance Qualification (PQ) protocols for new and existing equipment. Ensure equipment meets regulatory standards (e.g., FDA... qualification protocols (IQ, OQ, PQ). Familiarity with regulatory requirements (e.g., ISO, OSHA) Proficiency with diagnostic tools...
required progress of the project. Top 3 Keywords: 1- Equipment Qualification (IQ/OQ/PQ) 2- GMP/Regulatory Compliance 3- Root Cause... Analysis & Process Improvement (FMEA, Six Sigma, DMAIC) Top Required Skills: Equipment Qualification (IQ, OQ, PQ...
matrices, and validation reports. Execute IQ/OQ/PQ testing, risk assessments, data integrity (ALCOA+) evaluations, and change... processes, batch records, deviations, CAPAs, and data integrity (ALCOA+). Experience with system validation including IQ/OQ/PQ...
of PQ - Product qualification OQ - Operational Qualifications IQ - Installation Qualification Oversee all utilities...