/OQ/PQ, etc.). Monitors emerging regulatory health authority requirements for GxP computerized systems, process controls...
technologies, and computerized systems. Develop and oversee validation master plans, protocols (IQ/OQ/PQ), and reports for new...
/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...
PQ submissions as required. Serves as representative to gather and interpret new and changed regulations and guidelines... submissions (Pre-submissions, 510(k), De Novo, PMA, IVDR Class A, B, C or D or WHO PQ). Critical review of study protocols...
. Expertise in process validation and cleaning validation protocols – IQ/OQ/PQ. Working knowledge of GMP’s, SOP’s, CAPA, auditing...
projects. Drive process improvements, change control, and validation activities (TMVs, IQ/OQ/PQ). Direct preventive...
. Lead or support process validation activities (IQ/OQ/PQ), including protocol development and execution. Identify, audit...
strategies, and on-going controlled environment data. Reviewing SOP, URS, DQ, TQ, IQ, OQ, PQ’s and Change Controls...
strategies, and on-going controlled environment data. Reviewing SOP, URS, DQ, TQ, IQ, OQ, PQ’s and Change Controls...