readiness. Oversee prototype builds, tooling design/build, and validation activities (IQ/OQ/PQ). Align manufacturing readiness...
, protocols (IQ/OQ/PQ), and reports for computer systems. Assess and document system requirements, risk assessments, and user...
/Equipment Transfer Lead and execute process and equipment validations (IQ/OQ/PQ) for new, transferred, or modified products... with product and process requirements. Lead cleanroom qualification and requalification activities (IQ/OQ/PQ) and establish...
sustainable CAPA. Project review and commissioning OQ, PQ, DQ, IQ Development of site-specific SLA with the Cleaning Contractors...
and product monitoring, including the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations. Provide...
and execute engineering and validation protocols, to support process validations (IQ/OQ/PQ) and the creation of statistically...
FUNCTIONS/SKILLS: Development and execution of documents including but not limited to: FAT, SAT, IQ, OQ, PQ, and PV Review..., Data Integrity Assessments, IQ, OQ, PQ, Summary Reports, URS, FRS, DS and Traceability Matrix. Familiar with Development...
testing systems. • Participate in IQ/OQ/PQ (Installation/Operational/Performance Qualification) of test and diagnostic...
and product monitoring, including the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations. Provide...
(OQ), performance qualifications (PQ), and process performance qualifications (PPQ). Provide technical mentorship...