requirements for process implementation and validation (IQ/OQ/PQ). Ensure manufacturing equipment runs at optimal performance...
and quality standards, including FDA requirements where applicable. Support validation activities (IQ/OQ/PQ) for new and existing... such as Medical Device, Pharmaceutical, Food, or Consumer Products. Working knowledge of validation processes (IQ/OQ/PQ) and FDA...
and DFMEA, lead statistical studies with executive summaries, DOE, IQ-OQ-PQ, measurement and test methods, GR&R studies...
writing, IQ/OQ/PQ execution). General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, healthcare compliance and regulations...
qualification protocols (IQ/OQ/PQ). Knowledge of laboratory-specific engineering systems including fume hoods, biosafety cabinets...
qualification (PQ) and process verification (PV) run stage of the new product introduction to ensure proper procedures and methods... to assist them with the introduction of new products at PQ/PV. Skills/Requirements High School Graduate. Able to perform...
and execute engineering and validation protocols, to support process validations (IQ/OQ/PQ) and the creation of statistically...
validations (IQ/OQ/PQ), ensuring compliance and robust process performance. Manage PPAP deliverables and oversee supplier...
, and demo sessions Support SIT, UAT, PQ, and production deployments in coordination with business and QA teams Ensure...
assurance controls Write validation and verification plans and protocols, assist with IQ/OQ/PQ activities, including finalize...