, including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and IQ/OQ/PQ test scripts...
finalisation through to PQ (Performance Qualification). Key Responsibilities 1. Technical Ownership & Design Integrity System...
investigations and manage CAPA implementation. Review and approve validation protocols (IQ/OQ/PQ) for products and processes...
documentation Experience with commissioning and qualification (IQ/OQ/PQ) Excellent communication and client-facing skills...
site validation activities: Review of DS & QRAES documents Review of validation Plans, Protocols, IOQ, PQ...
documents o Review of validation Plans, Protocols, IOQ, PQ and associated validation documents o Review of executed...
testing would be an advantage Strong knowledge in operation and qualification of lab equipment (IQ/OQ/PQ...
site validation activities: Review of DS & QRAES documents Review of validation Plans, Protocols, IOQ, PQ...
) Operational Qualification (OQ) Performance Qualification (PQ) Traceability Matrices Support system change controls, periodic...
standards. Act as System Owner (SO) for syringe filling equipment from design through to PQ and commercial operation.... SO during equipment implementation, FAT/SAT, commissioning, qualification (IQ/OQ/PQ), and validation activities. Drive manufacturing...