Syngene Ltd QC Clinical Executive Job Vacancy – Apply Online
Syngene Ltd invites candidates with a bachelor’s degree in pharmacy for the post of the executive.B Pharma job opening 2021, B Pharma job opening 2021, Executive clinical job vacancy 2021, Interested candidates check out all the details on our website Rasayanika.com
Job Title: Executive – Clinical QC (HPU)
Req Id: (35826)
Educational Qualification: B.Pharm, B.Sc, B.tech, M.Sc
Knowledge on MS office, Clinical Trials, and good verbal communication.
Experience: 1 – 3 Years
Behavioral Skills: Flexible, Quick learner, Adaptable, efficient in work and focused.
Job Purpose: Study and System-related activity monitoring and documents reviewing process with respect to SOPs and regulatory guidelines as per Clinical trial study requirements.
- Perform QC checks of the 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 study
- QC check for source documents transcribed data with CRF entries and other study-related documentation
- Provide Line clearance, Line Opening, and Line Cleaning to the Lab technician for the generation of Labels pertaining to Vacutainers and RIA vials.
- Issue True copy of verified calibration/validation reports for display in their respective areas.
- Coordinating 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 and when required.
- Provide Line clearance, Line Opening, and Line Cleaning for dispensing labels in the pharmacy.
- Archival of all study files.
- Provide the response to sponsor/QA observation noted during their data review or visit to the facility in coordination with HPU staff. Checking logbooks on weekly and month-wise and maintaining track on the calibration of equipment used in HPU.
- Prepare and Present trend analysis to HPU team once in six months or as and when needed as per HOD instructions.
- To carry out any other responsibility as and when assigned by the Head-Human Pharmacology Unit / Head of Syngene Clinical Development Team
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