all quality requirements, including PPAPs, Validations (IQ, OQ, PQ), complaints, SCARs, CARs, on-site audits, and product quality...
/Annex 11, GDP, and SOX controls;author configuration documentation and support validation (VP, IQ/OQ/PQ), change control...
Orders, Service Tickets). Lead and participate in IQ / OQ / PQ activities on process equipment. Act as user representative...
Engineering Change Order and Change Control processes. Collaborate with R&D on OQ and PQ execution and completion for product...
, and change control. Review and approve validation protocols (IQ, OQ, PQ), test methods, and manufacturing documentation...
related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good...
teams on process and product validation activities (IQ/OQ/PQ). Ensure calibration and maintenance programs meet ISO, FDA...
requirements, including PPAPs, Validations (IQ, OQ, PQ), complaints, SCARs, CARs, on-site audits, and product quality requirements...
validation strategy (IQ/OQ/PQ) and ensure revalidation triggers are embedded in change processes. Apply advanced statistical...
and review of DMR/DHR documentation and execution or review of validation protocols (IQ, OQ, PQ). Develop, review, and maintain...