validation activities, aligned with IQ/OP/PQ principes where applicable Author validation protocols, risk assessments and final...
/PQ), ensuring instruments meet audit trail, system control, and data integrity requirements. Strengthen OOS/OOT...
, build, unit testing, and demo sessions Support SIT, UAT, PQ, and production deployments in coordination with business...
Engineering and other departments. Creates and directs process/equipment validations (IQ, OQ, PQ). Reviews customer contracts...
validation protocols and reports including IQ, OQ, and PQ documentation Support equipment qualification activities... Strong understanding of cGMP, FDA regulations, and validation principles Experience with IQ/OQ/PQ protocol execution and report generation...
), IQ/OQ/PQ documentation, and regulated environments. Familiarity with Agile/Scrum development methodologies...
, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs...
including IQ/OQ/PQ protocols and execution. Collaborate with cross-functional teams including Quality, R&D, Regulatory Affairs... experience within the medical device or regulated industry. Experience with process validation (IQ/OQ/PQ), GMP, and FDA...
, build, unit testing, and demo sessions Support SIT, UAT, PQ, and production deployments in coordination with business...
manufacturing processes Lead IQ, OQ, and PQ validation activities Manage medium to large capital equipment projects Troubleshoot... guidance Required Skills IQ, OQ, PQ validation experience Capital project management experience Statistical analysis...