DescripciónDescription
Process Development Scientist to validate and document processes in a highly regulated environment for pharmaceutical/biotech processes.
Will operate specialized laboratory equipment and computers as appropriate.
Interpret and apply GLPs and GMPs.
Apply a science-based approach to production.
Development and Execution of Processes/Equipment Characterization
Establish Testing Strategies
Design / Development of Characterization Protocols
Technical Reports Development
Validations, and technical reports to support SATs executions, document generation and challenge validations strategies.
Risk assessments and QRAES knowledge, to support risk assessments activities.
Develop solutions to routine technical problems of limited scope.
Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes as applied to new equipment installations.
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Requisitos Requirements
Doctorate or Master's degree and 5 years of Scientific experience or
Bachelor's degree and 6 years of Scientific experience
Basic technical report and validation protocol writing
Bilingual (Spanish/English); verbal and written
Flexibility to work off-hours
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NO Requiere Experiencia
NO Experience Required
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Empleos en Puerto RicoJobs in Puerto Rico
QRC GROUP LLC
Empleos en Puerto RicoJobs in Puerto RicoProfesionales
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