Sr. Computer Systems Validation Analyst
(VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems. Author documents related to GxP...
(VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems. Author documents related to GxP...
to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps . Support inventory accuracy goals through regular...
. Significant background in engineering testing and analysis including: Direct experience of test equipment validation (IQ, OQ, PQ...
processes Process validations (IQ/OQ/PQ) Strong knowledge of regulatory standards (e.g., ISO, FDA-GMP) Proficiency...
Validations (IQ, OQ, PQ) Experience developing manufacturing processes and technologies, which includes process characterization...
to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps . Support inventory accuracy goals through regular...
MES, LES, ERP (SAP), and shop-floor equipment (PLCs/SCADA). Execute and document computer system validation protocols (IQ/OQ/PQ...
(FAI) Process Validation (IQ/OQ/PQ) PPAP elements (Control Plans, PFMEA, Process Flow, Capability Studies) Ensure...
and support DV, OQ, and PQ activities in accordance with CLIENT validation requirements. Ensure completion of required technical...
/OQ/PQ protocols for equipment, utilities, and systems Review and complete documentation in accordance with cGMP, ALCOA...