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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Education / Training |
| Functional Area | Quality (QA-QC) |
| EmploymentType | Full-time |
Perform QC checks of draft protocol, draft CRF, draft ICF and other study related requirements.Observing the pre-check-in, check-in, pre-dose, dosing, post-dose activity as per protocol, SOP/IOPs regulatory guidelines as required.Perform Periodic checks for essential documents filed in TMF or study related files at different stages such as before study activity starts, during the study and after the completion of the study100% QC check for source documents transcribed data with CRF entries and other study related documentationProvide Line clearance, Line Opening and Line Cleaning to the Lab technician for the generation of Labels pertaining to Vacutainers and RIA vials.Issue controlled copy of verified calibration / validation reports for display in their respective areas.Co-ordinating with sponsor and monitor s representatives during their visit for monitoring the study activity and assisting them with the documentation activity related to study procedure.Checking draft SOP/IOPs as requireChecking log books on weekly and month wise and maintaining track on calibration of equipment s used in HPU.To carry out any other responsibility as and when assigned by the Head-Human Pharmacology Unit / Head of Syngene Clinical Development Team.,
Keyskills :
baggagehandlingsystems validationreports clinicaldevelopment regulatoryguidelines qc crf ria tmf visit labels checks clinical protocol equipment regulatory monitoring validation completion calibration cf