Validation and Verification processes, Process Validation (IQ/OQ/PQ) Documentation & Records Management: Proficient in creating...
), and Performance Qualification (PQ) in accordance with industry standards and regulatory requirements. Quality Assurance Process... methodologies, including IQ/OQ/PQ, and risk management tools. Proficient in designing and analyzing quality systems, statistical...
. Expertise in process validation and cleaning validation protocols – IQ/OQ/PQ. Working knowledge of GMP’s, SOP’s, CAPA, auditing...
-on experience in Process validation (IQ, OQ & PQ) activities. Lead or support complaint investigations and resolution related... & PQ) activities...
in a regulated MedTech environment. If you have hands-on experience with IQ/OQ/PQ, calibration, and process capability.... Author and maintain IQ/OQ/PQ protocols & reports +validation documentation. Support Master Validation Plans, FMEA/risk...
/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems...
of Quality tools/methodologies including process validation (IQ, OQ, PQ). Understanding of statistical analysis and sampling...
activities with a focus on equipment performance qualification (PQ) and ensuring adherence to validation schedules and compliance...
lead on equipment project management from the URS issue to PQ by applying current project managements practices including...
protocols, review results, and/or draft/review reports for sterilization validations under IQ/OQ/PQ framework in conformance...