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Clinical Qa Auditor - Ba/Be

2-5 years
Not Disclosed
10 Dec. 23, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ M.Sc 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

Here's the structured job description for the BA/BE Study Auditor role:


Qualification

  • B.Pharm, M.Pharm, or M.Sc in relevant fields.

Roles and Responsibilities

1. Auditing and Compliance

  • Plan and conduct BA/BE study audits (both in-process and retrospective) ensuring compliance with study protocols, SOPs, and GxP standards and regulations.
  • Ensure audit activities are in line with regulatory requirements and GxP guidelines throughout the study lifecycle.

2. Review of Documents

  • Review draft protocols, study ICFs (Informed Consent Forms), and study CRFs (Case Report Forms) to ensure adherence to applicable GxP standards and regulations.
  • Assess eCTD (electronic Common Technical Document) submissions and Clinical Study Reports to confirm compliance and accuracy.

3. Document Review and Feedback

  • Provide timely document review comments to ensure compliance with study protocols and regulatory requirements.
  • Issue audit reports to the auditee and review responses, including Corrective and Preventive Action (CAPA) plans.
  • Ensure closure of audit reports within the stipulated timeline after reviewing audit responses and assessing CAPA.

4. Continuous Improvement

  • Ensure consistent monitoring and follow-up to improve quality and maintain GxP compliance.
  • Provide support in maintaining and updating audit and compliance standards.

This role is crucial in ensuring that the BA/BE studies are conducted with high compliance and quality standards, with a focus on timely audits and documentation. Would you like to make any changes or additions?