qualification (PQ) studies utilizing biological indicators to verify sterilization efficacy and process reliability. Perform...
and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities... maintenance of validated state. Author and execute IQ/OQ/PQ protocols, and reports for equipment and computerized systems in QC...
and execute DOE, TMV, PCR, IQ/OQ/PQ studies. Apply statistical analysis and advanced problem-solving to improve processes..., TMV, IQ/OQ/PQ, Process Validation, and Statistics. Strong analytical, troubleshooting, and project leadership skills...
, process validation (IQ/OQ/PQ), and manufacturing transfer activities to ensure product quality and readiness. Review... with Quality Management Systems (ISO 13485, FDA 21 CFR Part 820/QMSR), supplier qualification, process validation (IQ/OQ/PQ), root...
/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated..., IQ, OQ, PQ, FAI) of new supplier manufactured components. Strong communication skills and ability to work well...
testing of quality products. Train customers on equipment operation. Provide PQ consulting to assist customers with test...
, and continuous improvement methodologies. Experience with equipment validation, IQ/OQ/PQ protocols, and process qualification...
), process validation (IQ/OQ/PQ), and test method validation activities. Participate in continuous improvement initiatives... and ISO 13485. Exposure to process validation activities (IQ/OQ/PQ), DOE, and risk assessment tools such as PFMEA. Knowledge...
, and validation documentation. Support product and process validation activities, including IQ/OQ/PQ, process validation, cleaning...
equipment, utilities, facilities, and systems. Develop and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ documentation...