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Qa Auditor - Clinical

6-9 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: Clinical QA Auditor
Location: Bangalore
Date: 31 Dec 2024

Job Description:

The Clinical QA Auditor will perform in-process and retrospective audits of clinical studies, ensuring compliance with internal SOPs, protocols, and regulatory guidelines. This role also involves database audits, document reviews, CAPA implementation, and vendor audits. The Clinical QA Auditor will work closely with the operations team, preparing audit reports, reviewing documents, and ensuring that all quality assurance (QA) procedures are adhered to.

Key Responsibilities:

  • Conduct in-process audits based on study design and risk.
  • Perform retrospective audits of clinical study documents to ensure compliance with protocols, SOPs, and regulatory guidelines.
  • Audit databases in EDC applications for applicable studies.
  • Prepare audit reports and track the implementation of CAPA.
  • Review draft documents like Protocols, ICD, CRF, etc., before finalization.
  • Assist in system audits, vendor audits, and the preparation of CAPA during internal and external audits and inspections.
  • Archive QA records periodically and assist in trending quality metrics.
  • Escalate any serious non-compliance issues to the Manager/Department Head.

Required Qualifications:

  • Education: M.Sc or M. Pharm.
  • Experience: 6-9 years in auditing.
  • Skills: Auditing, regulatory understanding, attention to detail.

Behavioral Skills:

  • Strong auditing and regulatory knowledge.
  • Attention to detail with the ability to identify non-compliance issues.
  • Effective communication skills for collaboration across teams.

Syngene Values:

  • Excellence
  • Integrity
  • Professionalism