execution of equipment and process IQ/OQ/PQ. Ensure compliance with FDA regulations and the company’s quality requirements...
and execute design verification and validation activities, including process validation IQ/OQ/PQ/PPQ. Actively participate...
writing and executing validations (IQ, OQ, PQ, etc.). High-speed/high-volume custom automation experience, preferably...
instructions and process documentation Lead IQ/OQ/PQ process validation Partner with vendors to design/build assembly equipment...
. Responsibilities: Author, execute, and summarize commissioning and qualification deliverables including FAT/SAT, IQ, OQ, PQ protocols...-on CQV experience in pharmaceutical, biotechnology, and/or medical device industries Direct experience executing IOQ/PQ...
Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation...
Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation...
, IQ, OQ, PQ protocols and reports for process equipment, clean utilities (WFI, clean steam, gases), HVAC/cleanrooms... experience executing IOQ/PQ on automated equipment (filling lines, isolators, lyophilizers, device assembly equipment strongly...
Level Risk Assessments), DI (Data Integrity) Assessments, DR/DQ, Specifications, IQ/OQ/PQ Qualification Protocols/Issues...
, including vendor assessments, system risk assessments, validation plans, requirements specifications, IQ/OQ/PQ protocols...