Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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?