, DS, Risk Assessments, IQ/OQ/PQ protocols and reports, Traceability Matrices, Error Logs, Configuration Documents.../OQ/PQ/UAT) across Agile and traditional SDLC models. Deep understanding of CSV/CSA risk assessments, including GxP...
or mechanical production. Strong knowledge of lean manufacturing principles, DFM, and process validation (IQ/OQ/PQ). Experience...
, materials, and process deviations. Validation & Compliance (GMP/ISO): Develop and execute validations (IQ/OQ/PQ) for new molds...
execution experience to provide execution support (IQ, OQ, PQ) for systems and equipment including process vessels, buffer... execution support (IQ, OQ, PQ) for process vessels, buffer vessels, filter presses, centrifuges, CIP skids, clean rooms, WFI, RO...
) activities (IQ/OQ/PQ, evidence, traceability). Participate in internal and external audits related to Fusion PLM and IT systems...
planning, testing (IQ/OQ/PQ), detailed documentation, change control around computer systems for quality, manufacturing...
, validation protocols, and controlled documentation (e.g., IQ/OQ/PQ, PPQ, VSR) and coordinating training for operations...), Performance Qualification (PQ), Validation Summary Report (VSR), Configuration Qualifications (CQ), and Process Performance...
and professional response to customer concerns Plan and execute process validations (IQ/OQ/PQ) across multiple manufacturing steps...
and integration Exposure to validation and qualification activities (e.g., IQ/OQ/PQ) and familiarity with common documentation...
process engineering input through the design process for requirements and PQ testing Communicate clearly with laboratory...