QC Executive Job in Bangalore at Syngene

Syngene is hiring for the role of QC Executive1

Responsibilities of the Candidate:

• 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. 
• 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 and when required.
• Provide Line clearance, Line Opening and Line Cleaning for dispensing labels in pharmacy.
• Provide the response to sponsor/QA observation noted during their data review or visit to facility in coordination with HPU staff. Checking log books on weekly and month wise and maintaining track on calibration of equipment's used in HPU.
• Prepare and Present trend analysis to HPU team once in six months or as and when needed as per HOD instructions

Requirements:

• B.Pharm, B.Sc,  M.Pharm, M.Sc, BE
• 0-2 years