Resultados de la búsqueda: 12 vacantes
...Shift.
Experience in:
Process Validation Lifecycle (IQ,OQ,PQ,TMV/MSA).
Equipment Troubleshooting
Equiment Validation Protocols (Generation and Execution).
New Product Introduction
The Personality Part:
~ Our Next Piece is someone who treats everyone...
...requerimientos de las especificaciones.
Verifica conteo de la totalidad del "batch" de producción.
Participar en corridas de protocolos, validaciones y en procesos de auditorías cuando son requeridos.
Asistir durante el proceso de línea clara (Line Clearence) en...
...Responsible for an immediate notification and awareness to Quality Management of potential Quality situations.
#Assist and coordinate protocols.
# Provide training as required on: Good Documentation Practices, SPC, Total Integrated Quality and others.
# Provide support...
...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...
...Knowledge in 21 CFR Part 820 regulation.
Experienced (3-5 years) in the development and execution of validation documentation and protocols, including; Validation Assessments, Validation Plans, Requirements Specifications (URS, FRS), IQ, OQ, PQ and Reports....
...USA.
Responsibilities:
Engineer or Specialist in charge for equipment and process validation including IQ, OQ, TMV/MSA, PQ protocol generation and execution.
Resource will be hands-on with automation, tooling, and maintenance technicians to coordinate and follow...
...problems.
What are the top 3 things you are looking for in a candidates experience:
# experience in equipment validations protocol generation, execution and report
# good time management skills to comply with timeline
# good team member
Education...
...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...
...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 (...
...position:
~Validation Specialist
~Provides technical and project leadership.
~Develop test method qualification and validation protocols.
~Ensure validation master plans comply with regulatory agency requirements.
~Support regulatory submissions and regulatory...
...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...
