Perform instrument periodic reviews Roles & Responsibilities: Design and execute validation protocols (IQ/OQ/PQ...
. Develop and execute validation protocols (IQ/OQ/PQ) for laboratory instruments, equipment, and systems. Collaborate.... Strong understanding of regulatory requirements (GxP). Previous experience in equipment validation, particularly IQ/OQ/PQ processes...
System Validation (CSV) Review and approve CSV lifecycle documents (VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM...
and equipment (IQ/OQ/PQ) for new products. Design for Manufacturability (DFM): Collaborate with R&D to influence design, ensuring...
/PQ test cycles. Strong knowledge of analytical reporting, datasets, KPIs, and BI platform deployment. Proven...
(VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM, Summary Reports). Ensure risk-based validation approaches aligned...
plans (MVP, IQ/OQ/PQ) for supplier execution. Support incoming inspection teams as a technical expert to troubleshoot PCBA... and diagnostics for board level testing preferred Demonstrated experience developing process validation plans, including IQ/OQ/PQ...
: Experience with automated or manual inspection equipment. Experience performing IQ/OQ/PQ Validations Familiarity with ISO...
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...