improvement projects, etc;and the documentation required Develop, document, and qualify (IQ/OQ/PQ/PPQ) new manufacturing...
Facility capital project progresses through various stages including Process Qualification (PQ), Tech Transfer, Process...
validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT...
or CPG. Report all durability related issues to responsible Quality Improvement Team(s), AQIP, PQ, HATCI, and Suppliers...
with Factory Acceptance Testing, Process Validation and IQ/OQ/PQ’s. Must demonstrate knowledge of US regulatory and quality...
and reviewing URS, performing equipment qualifications (IQ, OQ, PQ), and generating essential documentation. This role exists... and regulatory standards. Perform Equipment Qualifications (IQ, OQ, PQ): Plan, execute, and document qualification protocols...
(FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release). Several years of SQA experience with Review... and Approval of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix and writing of System...
approval, build, runoff, FAT, software validation, IQ, OQ, and PQ road map requirements. Proven interpersonal...
, PQ protocols. Working experience in conducting Process Audits with the Procedures and Identify Gaps Skill...
: User Requirement Specifications Commissioning IQ, OQ, PQ Calibration Standard Operating Procedures Preventative...