Qualification (PQ), for both clean utilities (WFI, Purified Water, Clean Steam) and standard plant utilities. Lead commissioning...
/OQ/PQ) o Process & quality control activities o Process capability studies o Measurement system analysis studies...
ability to implement strategies that improve process efficiency Validation & Compliance: Experience with IQ/OQ/PQ...
, SAT IV/FTs, QRAES, PQ's associated with clean utility systems (WFI, Clean Steam, Process Air etc.) Ensures Startup...
and Automated Systems (QRAES). Generation , review and approval of Validation Plans, FAT, SAT IV/FTs, QRAES, PQ's associated...
equipment projects from URS development through PQ, applying current project management practices and ensuring GMP-compliant...
, QRAES, PQ's associated with clean utility systems (WFI, Clean Steam, Process Air etc.) Ensures Startup of equipment...
documentation (URS, FDS, IQ/OQ/PQ). Strong troubleshooting and problem-solving skills. Excellent communication and documentation...
with reliability and maintenance teams to minimize downtime. · Manage commissioning and qualification activities (IQ/OQ/PQ...
Review and approve qualification and requalification protocols (IQ, OQ, PQ) for equipment, systems, facilities, laboratories...