), 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 multi-tool molding programs end to end: from DFM input through process development, validation (IQ/OQ/PQ), and transfer... instructions, validation protocols (IQ, OQ, PQ), and standard operating procedures (SOPs). Collaboration and Cross-Functional...
results and recommendation in a timely manner Performs and review IQ’s, OQ’s and PQ’s of manufacturing, packaging, test...
, 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...
, equipment validation activities (IQ/OQ/PQ), and adherence to laboratory safety procedures when handling hazardous chemicals..., troubleshooting, and validation activities (IQ/OQ/PQ). If you are interested in this role, then please click...
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...
qualification (PQ) studies utilizing biological indicators to verify sterilization efficacy and process reliability. Perform...
, including IQ/OQ/PQ Excellent problem-solving, analytical, and communication skills Ability to work cross-functionally...
and execute qualification protocols (IQ/OQ/PQ) for GMP-critical utility systems, including Water for Injection (WFI) and Purified...
/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...