), and Performance Qualification (PQ) in accordance with industry standards and regulatory requirements. Quality Assurance Process... methodologies, including IQ/OQ/PQ, and risk management tools. Proficient in designing and analyzing quality systems, statistical...
protocols, review results, and/or draft/review reports for sterilization validations under IQ/OQ/PQ framework in conformance...
. Expertise in process validation and cleaning validation protocols – IQ/OQ/PQ. Working knowledge of GMP’s, SOP’s, CAPA, auditing...
in a regulated MedTech environment. If you have hands-on experience with IQ/OQ/PQ, calibration, and process capability.... Author and maintain IQ/OQ/PQ protocols & reports +validation documentation. Support Master Validation Plans, FMEA/risk...
Create and direct validations (IQ/OQ/PQ) Create PPAP documentation Other duties as assigned MPI does not discriminate...
CSV IQ/OQ/PQ scripting protocols and reports. Collaborate and build relationships with manufacturing groups to ensure...
in performing IQ, OQ, and PQ processes Provide statistical support to analyze manufacturing processes and to recommend appropriate...
lead on equipment project management from the URS issue to PQ by applying current project managements practices including...
/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems...
, and maintain a validated state. The engineer will be responsible for creating validation protocols (IQ/OQ/PQ), performing.... Create and maintain validation documentation, including IQ, OQ, and PQ protocols and reports. Develop manufacturing...