. Review, approval and execution of commissioning and qualification activity including FAT's/SAT's IQ/OQ/PQ's. Support NPI...
. Liaise with installation and project engineers. Preparation and completion of IQ/OQ and PQ, validation and commissioning...
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 readiness, start-up...
defining User Requirements Specifications and executing FAT, SAT, IQ, OQ, PQ protocols Experience developing OEE measurement...
, and commissioning through to IQ/OQ/PQ and full commercial operation. Operational Readiness: Drive the facility start-up, process...
Qualification (IQ/OQ/PQ) Ensure objective evidence demonstrates compliance with design requirements. Quality & Regulatory...
of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments/ PVP). Participate in project...
within the new laboratory facility which will include support of equipment qualification (PQ), documentation generation of SOP...
, budgeting, and stakeholder coordination. Lead or support equipment qualification and validation activities (IQ/OQ/PQ...
to and all associated records updated accordingly Purchase and procure spare parts and relevant consumables To assist with IQ, OQ, PQ... consumables To assist with IQ, OQ, PQ of all new and existing equipment. To assist the QP, in the implementation of continuous...