SOP-driven validations, produce IQ/OQ/PQ deliverables, and ensure ALCOA+data integrity. Perform gap analyses..., FTIR, NMR, Polarimeter, XRD, Kaye Validators, and LIMS/Empower3 systems. Proven expertise in IQ/OQ/PQ protocols, RTM/VSR...
Validation Plan, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic...
validations in accordance with Master Validation Plans, including IQ, OQ, PQ, Gauge R&R, and software validation. Analyze...
and Process Characterization  OQ/PQ Protocol and Reports  IQ/OQ Protocols and Reports  PFMEAs  MVP/MVRs. o Experience...
Validation Plans, including IQ, OQ, PQ, Gauge R&R, and software validation. Perform IQ, OQ, and PQ activities for assigned...
both within and outside of AbbVie. Lead/support process validation activities (IQ/OQ/PQ/PPQ), including TMV. Mentor/lead product team...
, DQ, IQ, OQ, PQ protocols as well as summary reports. Lead and document troubleshooting efforts of issues encountered...
tablets/capsules to complex medical devices. They focus on equipment development, qualification (IQ/OQ/PQ), troubleshooting..., pneumatic, and control subsystems. Develop and execute equipment qualification protocols (IQ, OQ, PQ) to support regulated...
Qualification (IOQ/PQ) Quality System Experience (Veeva, Trackwise, ComplianceWire) Medical Device or Pharmaceutical Experience...
assessments related to equipment reliability and support validation activities, including IQ/OQ/PQ protocols. Manage budgets...