/OQ/PQ, etc.). Monitors emerging regulatory health authority requirements for GxP computerized systems, process controls...
scale-up, facility readiness, equipment installation, qualification (IQ/OQ/PQ), and operational handoff. Ensure new...
strategies are defined and executed (e.g., DV, PV, IQ/OQ/PQ) Collaborating with Supply Chain and Supplier Quality to qualify...
technologies, and computerized systems. Develop and oversee validation master plans, protocols (IQ/OQ/PQ), and reports for new...
, and reduce costs Perform equipment and process validation (IQ/OQ/PQ) to ensure equipment meets specifications, performance...
combination products preferred), with a focus on Operations Quality (IQ/OQ/PQ), process/continuous improvement, CAPA activities...
/PQ protocols, Test Scripts, Traceability Matrix, and Validation Summary Reports. Establish and enforce traceability... hands-on IQ/OQ/PQ execution and risk-based validation approaches. Strong working knowledge of GxP regulations, FDA 21 CFR...
, and validation protocols (IQ/OQ/PQ). Collaborate with suppliers on injection molding, precision machining, and subassembly... testing. Hands-on experience in process design, DOE, root cause analysis, SPC, and validation (IQ/OQ/PQ...
with medical device regulatory requirements (IQ,OQ, PQ), and compliance requirements related to deploying machine vision system...
requirements, including ownership of process validation (IQ/OQ/PQ), documentation, and audit support Cross-functional... Skills: Strong technical background in process validation (IQ/OQ/PQ), statistical process control (SPC), and data driven...