System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and summary reports Lead...
, interference, reference interval studies) Experience with process validation (IQ/OQ/PQ), analytical method validation, and design...
, HMIs, OPC UA. IBM Maximo experience. Experience in GxP-regulated environments. Experience with validation (IQ/OQ/PQ...
activities (IQ/OQ/PQ) and change control processes as needed Review and Close Preventive and Corrective workorders as the...
Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product...
), IQ/OQ/PQ documentation, and regulated environments. Familiarity with Agile/Scrum development methodologies...
/OQ/PQ Process Validations. Perform Test Method Validation (Gauge R&R) and Software Validation. Manage BOMs and product.... Experience with: Process Validation (IQ/OQ/PQ) Test Method Validation (Gauge R&R) PLM Systems ERP/MRP Systems Statistical...
. Lead supplier-related projects such as process transfers, IQ/OQ/PQ validations, and capacity expansion initiatives...
Experience with validation activities including IQ/OQ/PQ and process characterization Familiarity with Statistical Process...
planning, and execution of IQ/OQ/PQ documentation. Ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+ data integrity...