Generation of Change control and System Impact Assessment (Kneat)
Review vendor documents for completeness
Provide SAT support
Validation document generation and protocol for equipment, including, but not limited to, process equipment and utility systems, both paper or using e-validation systems (Kneat)
Execution of IQ and review/support for OQ.
Closure of Change Control implementation tasks
Work independently with the project manager, vendors, and contractors
Provide Quality service adhering to SOP requirements
Give necessary support for the timely completion of projects
Be present on-site to provide full-time support.
Computerized systems in particular to Agilent LCMS and GCMS