Work closely with the project team and end-users through the full software life cycle of system scoping requirements gathering technical specifications change control qualification deployment and training.
Provide in-person and online training live demos on current business processes and system changes to end user community.
Create training materials for in-person web-based video and document-based training.
Create detailed business analysis use cases outlining problems process maps finding opportunities and solutions for improvement including communicating recommendations as well as technical challenges.
Author and update technical documentation including SOPs Work Instructions and User Manuals.
Contribute and assist in review of technical documentation including Change Management Records Design Specifications Configuration Specifications Validation Protocols Validation Reports and other Computer System Validation documentation.
Co-ordinate with business users on review and updates to requirement specifications user acceptance tests.
Co-ordinate with cross-functional stakeholders such as System Manager QA Business Process Owners and End users etc.
Maintain regular communications with business to address changes to plans/schedules.
Requirements:
Experience working in Biotechnology and Pharmaceutical laboratories for R&D or QC testing.
Good understanding of Drug Development and QC processes.
Experience as business analyst for Laboratory Informatics systems such as LIMS ELN LES CDS systems.
Must have experience as a trainer.
Experience in ELN systems such as BIOVIA Workbook IDBS Bio book Cambridge Soft E-Notebook Values Smart Lab is beneficial.
Strong understanding of GxP regulations governing computer system validation and operations in biopharma industry. Strong communication/interpersonal skills technical writing analytical and problem-solving skills.
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