/ Environmental Monitoring Systems / Secure OT/IT Integration / Validation Protocols (IQ / OQ / PQ) / Data Integrity / System...
technologies, and computerized systems. Develop and oversee validation master plans, protocols (IQ/OQ/PQ), and reports for new...
Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ...
translation into executable recipes. Ability to define URS/FRS and support testing (IQ/OQ/PQ, UAT). Ability to architect...
activities for PAT systems: URS/FRS authoring, risk assessments (GAMP 5), Part 11/Annex 11 controls, IQ/OQ/PQ, UAT..., documentation, and audit preparation;ability to author URS/FRS and lead IQ/OQ/PQ/UAT. Strong analytical and problem-solving skills...
and tolerances for sensors and electronics. Process Validation (IQ/OQ/PQ): Lead the strategy and execution of Installation...
, and reduce costs Perform equipment and process validation (IQ/OQ/PQ) to ensure equipment meets specifications, performance...
‑run testing, user training materials, product quality (PQ) script creation, Non-Product Software System (NPSS) validation... needs and quality expectations. Driving adoption and compliance by creating training materials, supporting PQ testing...
combination products preferred), with a focus on Operations Quality (IQ/OQ/PQ), process/continuous improvement, CAPA activities...
& Delivery Excellence Lead Computer System Validation (CSV) activities: author/review test strategies, IQ/OQ/PQ, traceability...