safety perspective. Support contract manufacturing in performing equipment IQ, OQ, and PQ. Maintain and update packaging... to provide technical solutions. Proficiency in SolidWorks to create packaging concepts and drawings. Experienced with IQ/OQ/PQ...
, validation plans, requirements specifications, IQ/OQ/PQ protocols, traceability matrices, summary reports, and relevant SOPs...
manufacturing processes. Perform and analyze IQ, OQ, and PQ qualifications along with other validation activities. Lead PFMEA... medical device industry (pharmaceutical experience not applicable). Hands-on experience executing IQ, OQ, PQ, and conducting...
. Perform and analyze daily and weekly NIR IT (PQ) tests;report any significant deviations or test failures to the Quality... testing and knowledge of cGMP, PI, QC and PQ reporting preferred. Excellent organizational, time management...
validation planning, executing IQ/OQ/PQ protocols, and final report generation. Act as the primary point of contact...
activities (IQ/OQ/PQ where applicable), test summaries, validation summary reports, and release documentation to support system...
for product changes and process validations (IQ/OQ/PQ), including risk assessments, compliance verification, and coaching teams...
& development experience Experience with DV&V, OQ/PQ Test method validation experience Experience with statistical techniques...
and drive rapid issue resolution. Lead process validation, test method validation, and equipment qualification (IQ/OQ/PQ...
School/GED and at least 2 years (BA is PQ only) in associate degree in industrial or maintenance technology OR at least 2...