as a subject matter expert (SME) Process Quality Develop, review, and approve validation protocols (IQ/OQ/PQ), test methods...
. Job Responsibilities: Complete project/part qualification deliverables including Supplier pFMEA, Process Validations (IQ/OQ/PQ...
/OQ/PQ) Experience with aseptic processing, HVAC systems, or utilities Familiarity with ISO standards and FDA audits...
design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects... activities (IQ/OQ/PQ). Support internal and external inspections and investigations (including Quality and HSE). Maintain...
, and manage validation activities (IQ/OQ/PQ) to support the introduction or modification of automated and semi-automated... with all departments. Required Skills & Competencies Medical Device Validation (IQ, OQ, PQ) Statistical Process Control (SPC...
. Understanding of Test Method Validation, IQ, OQ, PQ approach as defined by AtriCure Quality System. Manufacturing Logistics...
from initiation through IQ/OQ/PQ, aligning stakeholders and timelines to deliver right-first-time qualifications. Technology... in analytical equipment qualification and lifecycle (IQ/OQ/PQ/periodic review). Expertise with asset management/CMMS software...
process validation planning and execution. Assume full ownership of PQ process validation planning, execution, and reporting...
& Qualification Support Partner with Quality and Validation teams to support IQ/OQ/PQ for solid dose equipment and supporting... regulatory standards. Experience supporting process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ...
. Experience leading CAPA and process validation (IQ/OQ/PQ) projects Experience in owning the introduction of new products...