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Clinical Qa Auditor - Ba/Be

Advity Research
ADVITY Research
2-6 years
Not Disclosed
10 Feb. 10, 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

Job Title: BA/BE Study Auditor

Qualification:

  • B.Pharm / M.Pharm / M.Sc

Roles and Responsibilities:

  1. Study Audits:

    • Plan and conduct Bioavailability/Bioequivalence (BA/BE) study audits (both in-process and retrospective).
    • Ensure compliance with study protocols, Standard Operating Procedures (SOPs), and applicable Good Clinical Practice (GxP) standards and regulations.
  2. Document Review:

    • Review draft protocols, study Informed Consent Forms (ICFs), and Case Report Forms (CRFs) for regulatory compliance.
    • Assess eCTD submissions and Clinical Study Reports (CSRs) for accuracy and adherence to guidelines.
  3. Audit Reporting & CAPA Management:

    • Provide timely document review comments and feedback.
    • Issue audit reports to the auditee and review corrective and preventive action (CAPA) responses.
    • Ensure timely closure of audit reports.

This role requires strong regulatory knowledge, attention to detail, and expertise in BA/BE study compliance.