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Hpu Qc

2-5 years
Not Disclosed
10 Jan. 29, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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

Job Title: HPU QC (Quality Control)
Job Location: Bangalore
Pay Grade:
Year of Experience:

Job Purpose:

Responsible for performing quality control checks on clinical study documentation and activities, ensuring compliance with regulatory guidelines, SOPs/IOPs, and internal procedures.

Key Responsibilities:

  1. Document Quality Control:

    • Perform QC checks of draft CRF (Case Report Forms) and other study-related documents.
    • QC check for source documents transcribed data with CRF entries and other study documentation.
    • Review of Clinical Study Reports (CSR) and appendices.
    • Perform periodic checks for essential documents filed in the TMF (Trial Master File) or study-related files at various stages (pre-study, during study, post-study).
    • Archival of all study files in compliance with SOP-GCP-HPU-0065.
  2. Study Activity Monitoring:

    • Monitor pre-check-in, check-in, pre-dose, dosing, and post-dose study activities as per the study protocol, SOPs, IOPs, and regulatory guidelines.
  3. Line Clearance and Labeling:

    • Provide Line clearance, Line Opening, and Line Cleaning to Lab Technicians for the generation of labels pertaining to vacutainers and RIA vials.
    • Provide Line clearance for dispensing labels in the pharmacy.
  4. Reporting and Analysis:

    • Generate quality control reports for study activities and/or supporting documents.
    • Prepare and present trend analysis reports of observations to the Head of HPU and reporting managers, monthly or as directed.
    • Verify the response to sponsor/QA observations noted during their data review or visits to the facility in coordination with HPU staff and investigators.
  5. Qualification and SOP Reviews:

    • Review qualification documents as required.
    • Review SOPs/IOPs when necessary to ensure compliance and quality control processes.
  6. System QC and Issue Resolution:

    • Perform quality control checks of HPU facility systems and issue QC reports.
    • Coordinate with the concerned departmental person/Head of HPU to resolve any observations or clarifications pertaining to systems.
  7. Additional Responsibilities:

    • Issue True Copy of verified calibration/validation reports for display in their respective areas.
    • Carry out any additional responsibilities as assigned by the Head of Human Pharmacology Unit (HPU) or Head-Syngene Clinical Development.

Required Qualifications:

  • Relevant experience in Quality Control and Clinical Development or related fields.

Skills and Capabilities:

  • Attention to detail and thorough understanding of clinical trial documentation and processes.
  • Ability to review and ensure compliance with regulatory standards.
  • Proficient in preparing and presenting detailed reports.
  • Strong communication and coordination skills for collaborating with internal teams and stakeholders.

Equal Opportunity Employer:

Syngene is committed to providing equal employment opportunities regardless of age, color, national origin, disability, race, religion, gender, or any other characteristic protected by applicable laws. Reasonable accommodations for qualified individuals with disabilities will be provided.