Sr Manager, IT Clinical Systems Validation
Admin SOPs, Risk Assessments, User Requirements (URS), Test Protocols (IQ/OQ/PQ), etc. Create change controls, periodic...
Admin SOPs, Risk Assessments, User Requirements (URS), Test Protocols (IQ/OQ/PQ), etc. Create change controls, periodic...
validations (IQ/OQ/PQ), including analyzing results and developing reports;collaborate with cross-functional team members...
systems validation (CSV) activities, helping them understand how to create validation deliverables (Validation Plans, IQ/OQ/PQ... such as Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports. Demonstrated...
Level Risk Assessments), DI (Data Integrity) Assessments, DR/DQ, Specifications, IQ/OQ/PQ Qualification Protocols/Issues...
systems validation (CSV) activities, helping them understand how to create validation deliverables (Validation Plans, IQ/OQ/PQ... such as Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports. Demonstrated...
, including IQ/OQ/PQ protocols and reports. Knowledge of Gauge R&R studies and performing ranging studies/DOE to optimize...
, including vendor assessments, system risk assessments, validation plans, requirements specifications, IQ/OQ/PQ protocols...
. Create process flow diagrams, work instructions, PFMEAs, and validation protocols (IQ/OQ/PQ). Collaborate with suppliers...
systems validation (CSV) activities, helping them understand how to create validation deliverables (Validation Plans, IQ/OQ/PQ... such as Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports. Demonstrated...
capabilities in manufacturing. Performs or manages process validations (IQ/OQ, OQ, PQ). Troubleshoot production line issues...