requirement. o Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc. o Exposure to Regulatory... TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must. o Knowledge on working in Jira, HP ALM or any automation testing...
or formal continuous improvement training Knowledge of FAT, SAT, IQ, OQ, or PQ validation methodologies Experience with CMMS...
Complete project/ part qualification deliverables including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports...
Responsibilities: Lead validation activities for Labware LIMS 8 implementation Author and review IQ/OQ/PQ, RTM... Environment GAMP 5 & Regulatory Compliance IQ / OQ / PQ Documentation Requirements Traceability Matrix (RTM) Validation...
, compliant production. Key Responsibilities Validation Execution (Primary Role) Execute IQ, OQ, PQ, requalification...
) activities (URS, FRS, IQ/OQ/PQ, etc.). Author and maintain validation and compliance documentation. Act as system administrator...
Support URS revisions, readiness checklist packages, IOQ/PQ packages, and QSRs Maintain deliverable trackers, package status... environments Familiarity with URS, IQ/OQ/PQ, readiness checklists, QSRs, deviations, and traceability Strong attention to detail...
and PQ – Key Partner to Pilot on root cause investigations for manufacturing processes. Ensure development...
desirable. Demonstrated computer skills and familiarity with software programs such as Word, Excel, MeridianLink Loans PQ...
revisions, System Readiness Checklist revisions/executions, IOQ revisions/executions, PQ strategy/execution for new model units... execution strategy and documentation Author/revise URS, System Readiness Checklists, IOQ protocols, PQ documentation, and QSRs...