and execution of validation strategies including IQ/OQ/PQ for new and existing equipment. Apply Lean principles to identify waste... experience (or 8+years with a Master's degree). Strong expertise in medical device process validation (IQ/OQ/PQ...
multiple projects. PPAP, IQ, OQ, PQ, FMEA, CONTROL PLANS, DOE, GRR, risk management, problem solving Working within a Quality...
, 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...