/requalification (IQ/OQ/PQ) and maintain environmental monitoring programs (particulates, temperature, humidity, differential pressure... validation protocols (IQ/OQ/PQ) in alignment with FDA, ISO 13485, GMP, and internal quality standards. Ensure all processes...
/OQ/PQ). Provide assistance and/or perform inspection, and electrical safety testing. Ability to perform basic statistical...
(customer). Drive process validation and documentation (IQ/OQ/PQ, TMV's, Manufacturing Processes, Equipment Commissioning...
: Review GMP validation documentation for Risk Assessment, System Classification, URS, IOQ, PQ protocols and reports...
, 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...
including URS, FRS, risk assessments, IQ/OQ/PQ, and validation reports. Ensure compliance with FDA, GAMP 5, 21 CFR Part 11...
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...
controls Update documentation and data within the QMS Create and direct validations (IQ/OQ/PQ) Create PPAP documentation...
, and in compliance with the quality management system. This includes IQ/OQ and PQ process. Resolves problems such as production process...
), 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...