Posted:2 weeks ago|
Platform:
Work from Office
Full Time
These statements reflect the general description of the position and are not intended to be an all inclusive list of tasks to which employee may be assigned
A. Prepare Sample analysis report, Incurred sample reanalysis report & Method validation report in compliance with standard operating procedure and respective regulatory requirements such as USFDA, EMA, TGA, MCC, CANADA, NMPA, etc..
B. Ensure additional summary/module 2 (as applicable) is prepared as per respective regulatory and sponsor requirements.
C. Handle Sponsors or regulatory queries on lab reports.
D. To ensure that lab reports are released within their timelines.
E. Maintain documents and databases for the assigned projects.
Compile copies of Incurred sample reanalysis report, Method validation report and Sample analysis report for archiving.
Cliantha Research
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