documents, URS, IQ, OQ, PQ Requirements: Must be willing to work onsite at varying client locations, extensive travel...
and validation project plans Develop and execute IQ/OQ/PQ protocols Develop qualification summary reports Organizing and executing...
of FAT/SAT, IQ/OQ/PQ, and line acceptance criteria New Equipment & Supplier Interface Define mechanical requirements...
with mechanical requirements and GAMP 5 standards;own commissioning, validation, and qualification (IQ/OQ/PQ);and deliver secure... and GAMP 5 standards Ownership of commissioning, validation, and qualification (IQ/OQ/PQ) for automation-controlled systems...
validation activities including IQ, OQ, and PQ processes according to 21 CFR 820 and 21 CFR Part 11. Manage calibration programs...
), Performance Qualification (PQ), and Process Characterization (PC). Ensure compliance with industry-specific standards including..., as verified through references. Experience with plastic injection molding, IQ/OQ/PQ, statistical analysis, PPAP, APQP, supplier...
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports. Act...
are safe, compliant, and cost-effective. Lead process validation activities including IQ, OQ, and PQ. Design fixtures.... Experience in process validation (IQ/OQ/PQ). Understanding of risk management and process controls. Additional Skills...
to production. Conduct IQ/OQ/PQ validations for manufacturing equipment and ensure compliance with regulatory standards. Develop.../PQ, test method validation, and process characterization Familiarity with inspection equipment and quality control tools...
and internal quality system requirements. Lead validation activities including IQ/OQ/PQ, TMV studies, equipment qualification...