Resultados de la búsqueda: 7 vacantes
...Shift and 4th Shift.
Experience in:
Development of the protocols and report of CSV.
Technical Writing
Project Plans and Project... ..., modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials...
...Validation.
Prepare project plans and project progress reports.
Support development, review and approve Computer System Validations protocols for the medical devices industry.
Support development, review and approve Computer System Validations reports with rigor and...
...(NPI) and Process transfer activities in a regulated manufacturing environment.
Responsible to generate and execute validation protocols for new or replaced equipment, or process changes. Perform initial set-up, conduct and/or support troubleshooting, including continuous...
...Certification with PLC, Vision Systems, sensors, packaging process, automated equipment. FDA regulations, project management and validation protocols knowledge.
Four (4) years of previous experience
Computer literacy in MS Word, Excel, PowerPoint.
Basic Knowledge to read...
...validation packets.
~Validates and qualifies equipment for manufacturing and QC testing of product.
~Assists in writing validation protocols and reports and creates written maintenance procedures.
~Based on validation tasks performed, identifies and documents potential...
...support for ongoing compliance initiatives, assessments, corrective actions and trainings.
~Generate and execute quality validation protocols (IQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities.
~Conduct validation of process...
...well as understanding of how they are applied to regulatory compliance.
~Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
~SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (...