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Hpu Qc

2+ years
Not Disclosed
10 Jan. 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Title: HPU QC
Location: Bangalore
Date: 3 Jan 2025

Job Description:

Designation: HPU QC
Job Location: Bangalore

Core Responsibilities:

  • Perform QC checks on draft CRF (Case Report Form) and other study-related documents to ensure compliance with protocol, SOPs, and regulatory guidelines.
  • Monitor study activities, including pre-check-in, check-in, pre-dose, dosing, and post-dose, in accordance with the protocol, SOPs, and IOPs.
  • Conduct periodic checks for essential documents filed in the TMF (Trial Master File) or study-related files at different stages—before, during, and after the study.
  • Perform QC checks for source documents transcribed data with CRF entries and other study-related documentation.
  • Provide Line clearance, Line Opening, and Line Cleaning to lab technicians for generating labels for vacutainers and RIA vials.
  • Offer Line clearance, Line Opening, and Line Clearance for dispensing labels in the pharmacy.
  • Generate Quality Control reports for study activities and supporting documents.
  • Verify responses to sponsor/QA observations noted during their data review or visit to the facility, in coordination with HPU staff and investigators.
  • Review of CSR (Clinical Study Report) and appendices to ensure completeness and accuracy.
  • Ensure proper archival of all study files and ensure compliance with SOPs.
  • Verify oceasoft and archival according to SOP-GCP-HPU-0065.
  • Review qualification documents as and when required.
  • Prepare and present trend analysis reports on observations to the Head of HPU and reporting managers, monthly or as needed.
  • Issue True Copy of verified calibration/validation reports for display in the respective areas.
  • Review SOPs and IOPs as required to maintain compliance with standards.
  • Perform Quality Control checks of HPU facility systems, issue QC reports, and collaborate with concerned departmental heads to resolve observations and clarifications.
  • Carry out any additional responsibilities as assigned by the Head of Human Pharmacology Unit or Head of Syngene Clinical Development.