technical writing Analyst - Junior
Location
Beerse
Job Description:
Project/Department Description and responsibilities:
SDLC governance and oversight in the IT organization of pharmaceutical operations in (GPSG) is a global team that has responsibility for quality and process aspects of the IT function in that organization
Environment Development Tool(s) and Platform(s):
Strong knowledge of
Office (Word, Excel and Powerpoint primarily)
Knowledge of
HP Quality Center
IBM Clear Quest
SAP (basic functionality, principles of change management, authorizations,
)
Basic understanding of
Windows server,
Window security mechanisms,
Sharepoint
Object Oriented and Agile development processes
Primary Tasks and responsibilities:
Technical writing aspects of
o Implementation and maintenance of Standard Operating Procedures, work instructions and templates
o Maintenance and review of SDLC documents (user requirements, functional specifications, technical designs, test cases and test execution) and coordination of corrective actions
Qualification planning and cooperation with project teams to ensure SDLC activities are performed and reporting of project compliance status
Technical profile requirements:
Understanding of System Development Lifecycle processes, including testing
Understanding of document management processes
Understanding of quality processes in IT (ITIL, CMM, GAMP,
)
Understanding of GMP regulations and specially 21CFR part 11 impact on systems
Understanding of SOX controls in IT
General other compliance understanding: privacy, safety and health,
Technical writing skills to write the proper documentation according to internal regulations (FDA part 11, GxP,
)
o You can easily analyze processes, draw flow chart diagrams and describe processes in clear language. You have excellent (technical) writing skills (+3 years)
Qualification Rating
Clearquest *
2 (Limited Experience) of 5 (Expert)
and 1+ Yrs.
Microsoft Office
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