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Qa Auditor - Clinical

9-12 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 is responsible for performing study-specific audits to ensure compliance with in-house SOPs, protocols, and applicable regulatory guidelines. This role involves conducting in-process audits, retrospective audits of clinical study documents, database audits, and vendor audits. The Clinical QA Auditor will also manage audit reports, track CAPA implementation, and support quality metrics and internal audits, ensuring that all study processes adhere to the highest quality standards.

Key Responsibilities:

  • Perform study-specific in-process and retrospective audits to ensure compliance with SOPs, protocols, and regulatory guidelines.
  • Audit database entries in EDC applications for applicable studies.
  • Prepare and issue audit reports, tracking corrective and preventive actions (CAPA) to ensure timely closure of audit observations.
  • Conduct change control and follow-up for timely resolution in collaboration with the Manager/Department Head.
  • Review draft documents like Protocol, ICD, CRF before finalization.
  • Assist in system audits and vendor audits as a co-auditor or lead.
  • Provide GxP training to fellow QA personnel when required.
  • Ensure QA records are archived regularly and assist in trending quality metrics.
  • Participate in internal and external audits and inspections to maintain audit readiness.

Required Qualifications:

  • Education: M.Sc or M. Pharm.
  • Experience: 9-12 years of auditing experience.
  • Skills: Auditing, understanding regulations, and attention to detail.

Behavioral Skills:

  • Strong auditing skills and regulatory knowledge.
  • Attention to detail with the ability to spot non-compliance issues.
  • Strong communication skills to interact with various teams.

Syngene Values:

  • Excellence
  • Integrity
  • Professionalism