technologies, and computerized systems. Develop and oversee validation master plans, protocols (IQ/OQ/PQ), and reports for new...
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...
translation into executable recipes. Ability to define URS/FRS and support testing (IQ/OQ/PQ, UAT). Ability to architect...
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...
materials, product quality (PQ) script creation, Non-Product Software System (NPSS) validation, and the development of metrics...
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...
in process validation (IQ, OQ & PQ), experience with various production processing methods and the product/process development...
, OQ, PQ). Statistical Process Control: Develop and maintain SPC systems to monitor and improve product quality...