), and Performance Qualification (PQ) protocols for sterile manufacturing equipment. Conduct risk assessments (e.g., FMEA) to define... within a sterile injectables manufacturing. Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities. Experience...
validation documents (IQ/OQ/PQ)and summary reports for validation exercises Trouble shooting for risk assessments (mitigations...
and troubleshooting of equipment and its associated software. Writes, executes, reports and reviews IQ/OQ and PQ protocols...
Improvement initiatives based on NPI and prototype builds. Oversee QSR validation protocols (IQ, OQ, PQ) for NPI activity...
/PQ documentation, and validation reports. Perform statistical validation of inspection system performance including... including URS, functional specifications, IQ/OQ/PQ documentation, and validation reporting. Experience developing regulatory...
/PQ documentation, and validation reports. Perform statistical validation of inspection system performance including... including URS, functional specifications, IQ/OQ/PQ documentation, and validation reporting. Experience developing regulatory...
/OQ and PQ protocols so as to ensure that all relevant equipment is qualified for cGMP use. Performs routine and non...
support of equipment qualification (PQ), documentation generation of SOP's, Work instructions as well as contributing to lab...
. Develop and validate QSR protocols (IQ, OQ, PQ). Conduct internal audits to ensure Quality System compliance...
, calibration and troubleshooting of equipment and its associated software. Writes, executes, reports and reviews IQ/OQ and PQ...