Associate Technical Writer
Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation...
Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation...
, IQ, OQ, PQ protocols and reports for process equipment, clean utilities (WFI, clean steam, gases), HVAC/cleanrooms... experience executing IOQ/PQ on automated equipment (filling lines, isolators, lyophilizers, device assembly equipment strongly...
Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation...
Level Risk Assessments), DI (Data Integrity) Assessments, DR/DQ, Specifications, IQ/OQ/PQ Qualification Protocols/Issues...
, including vendor assessments, system risk assessments, validation plans, requirements specifications, IQ/OQ/PQ protocols...
methodologies. Lead process validation and qualification (IQ/OQ/PQ) for new or modified equipment. Conduct root cause analysis...
Maturation of all parts prior to mass production. Provide status updates with the PQ management team. Provide analysis...
, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis Work with suppliers to execute...
and prepare technical reports Perform IQ/OQ/PQ and maintain lab equipment Follow safety procedures and good laboratory practice...
protocols, review results, and/or draft/review reports for sterilization validations under IQ/OQ/PQ framework in conformance...