optimization in a manufacturing setting. Familiarity with cGMP, validation protocols (DQ, IQ, OQ, PQ), and FDA regulations...
/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems...
/QC) and methodologies for defect management is expected. Knowledge for formal validation protocols (e.g. GxP, IQ/OQ/PQ...
, PQ) using statistical tools (e.g., Minitab) for data analysis and decision-making. Oversee product testing and analysis...
) and PQ (Performance Qualification). Performs remedial maintenance on active instrumentation and equipment. Provides...
-of Line test equipment through IQ, OQ, PQ approvals (Hardware, Software, and Firmware) Drive project meetings with a focus...
, qualification (IQ/OQ/PQ), process validation, and PPQ batches to support NDA filings. 6. Contribute to CMC content, coordinate...
instructions, maintenance, and calibration procedures. Create and execute protocol documentation for equipment DQ, IQ, OQ, PQ...
manufacturing readiness. Validation & Verification Plan and execute IQ/OQ/PQ activities for equipment, processes, and software.... Experience with process validation (IQ/OQ/PQ) and risk-based approaches to manufacturing. Familiarity with PCB/SMT assembly...
welding to PQ-50202-38, PQ-50210-38 and PQ-50101-39) within progression period. Knowledge of shop mathematics, read/interpret...