Syngene Ltd QC Clinical Executive Job Vacancy - Apply Online

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

Job Title: Executive – Clinical QC (HPU)

Req Id: (35826)

Educational Qualification: B.Pharm, B.Sc,, M.Sc

Technical/Functional Skills:

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.

Key Responsibilities:

  • 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

Apply Online

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