, OQ, PQ) of assets and associated machines. Partner with Quality, Operations, CSV and other cross functional partners...
(where appropriate) Installation, Operating and Performance Qualification (IQ, OQ, PQ) of assets and associated machines. Partner...
management software, CRM, or ERP systems (Integro or equivalent). Knowledge of GAMP5, DQ/IQ/OQ/PQ validation frameworks...
with customer validation protocols (DQ/IQ/OQ/PQ). Produce technical documentation to GAMP5 standards where required by regulated... robot systems. Knowledge of pharma/life science validation - GAMP5, DQ/IQ/OQ/PQ, GMP. Degree or equivalent...
completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness. Coordinate project activities...
with customer validation protocols (DQ/IQ/OQ/PQ). Produce technical documentation to GAMP5 standards where required by regulated... robot systems. Knowledge of pharma/life science validation - GAMP5, DQ/IQ/OQ/PQ, GMP. Degree or equivalent...
. Validation Execution: Conduct and oversee Equipment Validation activities, including IQ, OQ, and PQ, ensuring all machinery...
, including Validation Master Plans (VMPs), Risk Assessments, IQ/OQ/PQ protocols, and summary reports. Leading tech transfers...
' post-OQ (PQ, PPQ) readiness. · Monitor costs and progress of process suite team milestones with all team members...
Execution & Commissioning Manage equipment installation, commissioning, and validation activities Coordinate FAT/SAT, IQ/OQ/PQ... with commissioning and qualification activities (FAT/SAT, IQ/OQ/PQ) Ability to interpret engineering drawings (P&IDs, PFDs, layouts...