Qualification (IOQ/PQ) Quality System Experience (Veeva, Trackwise, ComplianceWire) Medical Device or Pharmaceutical Experience...
Qualification (IOQ/PQ) Quality System Experience (Veeva, Trackwise, ComplianceWire) Medical Device or Pharmaceutical Experience...
, DQ, IQ, OQ, PQ protocols as well as summary reports. Lead and document troubleshooting efforts of issues encountered...
validation planning, executing IQ/OQ/PQ protocols, and final report generation. Act as the primary point of contact...
qualification protocols (IQ/OQ/PQ) and test method validations Ensure surface treatment (i.e. plasma, CO2 cleaning), adhesive...
/OQ/PQ). Provide assistance and/or perform inspection, and electrical safety testing. Ability to perform basic statistical...
and train production personnel. Develop the Validation Master Plans and perform process validations (IQ, OQ, PQ), including...
for commissioning and qualification of equipment, utility systems and facilities, including IQ, OQ, and PQ, Process functional...
, including IQ/OQ/PQ protocols and reports. Knowledge of Gauge R&R studies and performing ranging studies/DOE to optimize...
manufacturing readiness. Validation & Verification Plan and execute IQ/OQ/PQ activities for equipment, processes, and software.... Experience with process validation (IQ/OQ/PQ) and risk-based approaches to manufacturing. Familiarity with PCB/SMT assembly...