. 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...
and validation activities (IQ/OQ/PQ, MVP) and qualification planning Serve as technical lead on projects, supporting quoting...
activities (IQ/OQ/PQ) to implement new fixtures and equipment on new and existing production lines. Challenge specifications... Skilled in process validation (IQ/OQ/PQ) and equipment/fixture design for chemical finishing Familiarity with chemical safety...
SOP-driven validations, produce IQ/OQ/PQ deliverables, and ensure ALCOA+data integrity. Perform gap analyses..., FTIR, NMR, Polarimeter, XRD, Kaye Validators, and LIMS/Empower3 systems. Proven expertise in IQ/OQ/PQ protocols, RTM/VSR...