Quality Engineer
process validation activities, including IQ, OQ, and PQ protocols and reports. Act as a liaison with regulatory bodies...
process validation activities, including IQ, OQ, and PQ protocols and reports. Act as a liaison with regulatory bodies...
expectations. Support commissioning, qualification, and validation (IQ/OQ/PQ‑aligned testing methodology) of robotic systems...
in a production line Perform element of a Process Validation (IQ/OQ/PQ). Participate in activities related to new Product...
professionals. This person will have experience of a strong scientific or engineering background with CRDR IQ, OQ, PQ. The...
and quality requirements. Lead supplier validation activities (IQ, OQ, PQ), support initial builds and commercialization of new...
), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for cleanrooms, HVAC systems, compounding equipment.../211 regulations. Experience in creating, executing and documenting IQ/OQ/PQ protocols, risk assessments, and change...
including URS, FRS, risk assessments, IQ/OQ/PQ, and validation reports. Ensure compliance with FDA, GAMP 5, 21 CFR Part 11...
(OQ), and Performance Qualification (PQ) processes. Ensure sterilization and packaging meet regulatory standards... with IQ, OQ, and PQ validation processes. 3-5 years of experience in the medical device industry, preferred. Additional...
, strategic and project leadership to the Product Quality (PQ) organization. The PQL has responsibility for working with PQ staff...;specification, comparability, and stability programs;site and method transfers;product quality impact statements for NCs;and PQ...
Biorefining standard operating procedure. Perform NIR IT (PQ) testing on a weekly basis and report any test failures to the... of cGMP, PI, QC and PQ reporting preferred. Excellent organizational, time management and communications skills as well...