/OQ/PQ validation protocols for thermoforming and sealing processes in compliance with ISO 11607-2 and FDA process...;medical device experience strongly preferred. Hands-on experience with process validation (IQ/OQ/PQ). Strong working...
Apply manufacturing quality engineering toolsets including NCR, SCAR, MRB, PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control...
and equipment lifecycle management, including equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and CSV...
planning, and execution of IQ/OQ/PQ documentation. Ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+ data integrity...
Engineering and other departments. Creates and directs process/equipment validations (IQ, OQ, PQ). Reviews customer contracts...
/OQ/PQ Process Validations. Perform Test Method Validation (Gauge R&R) and Software Validation. Manage BOMs and product.... Experience with: Process Validation (IQ/OQ/PQ) Test Method Validation (Gauge R&R) PLM Systems ERP/MRP Systems Statistical...
Validation Plans and IQ/OQ/PQ protocols during product setup. Transition these into production by reviewing and optimizing the CM...
cause analysis. Develop and document IQ, OQ, PQ and maintenance protocols for new equipment and fixtures. Develop...
, including HEPA filtration, environmental monitoring, and utility performance. Enhance equipment qualification (IQ/OQ/PQ...
instruments, including installation, configuration, troubleshooting, & documentation (SOPs, IQ/OQ/PQ). Ensure ongoing data...