, and quality teams to resolve chronic equipment issues Support development and execution of FAT/SAT, IQ/OQ/PQ, and line acceptance...
activities for PAT systems: URS/FRS authoring, risk assessments (GAMP 5), Part 11/Annex 11 controls, IQ/OQ/PQ, UAT..., documentation, and audit preparation;ability to author URS/FRS and lead IQ/OQ/PQ/UAT. Strong analytical and problem-solving skills...
) Review and approve CSV lifecycle documents (VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM, Summary Reports). Ensure...
techniques such as IQ, OQ, PQ. Strong troubleshooting and process engineering skills. Experience in continuous improvement... years of experience with IQ, OQ, PQ. Minimum of 3 years of experience with validations and documentation. Additional...
new production introductions, process validation (IQ/OQ/PQ), and equipment commissioning Collaborate with tooling teams...
and process validation (IQ/OQ/PQ) projects Experience in owning the introduction of new products to production. Solid...
simple change controls and validation qualifications (IQ/OQ/PQ). Troubleshoot system/equipment-related issues...
, and PQ activities on new and existing products is a significant part of this role, along with creating and managing... Development Quality Matrices. Support IQ, OQ, and PQ activities for new and existing products. Create and manage Manufacturing...
principles Knowledge of GD&T Knowledge of DFMEA and PFMEA Validation;OQ, IQ, PQ, TMV Knowledge of Design for Automation...
and execute engineering studies, DOE protocols, and IQ/OQ/PQ documentation. Provide advanced technical support...