Junior Auditor - CRQA

Veeda CR; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Veeda CR is seeking a QA Auditor with strong experience in clinical studies to plan and execute audits in accordance with ICH-GCP and Indian GCP. You will review study documentation, CAPA closures, and ensure compliance across trials from phase 1 to BA/BE.

The role involves TMF audits and collaboration with QA and sponsor teams. Ideal candidates have hands-on experience with audit plans, SOPs, and regulatory inspections, and can interpret guidelines to support audit findings and corrective

Qualifications

• Experience conducting audits of clinical studies in compliance with ICH-GCP/Indian GCP.
• Ability to prepare audit plans and review protocols and CRFs.
• Experience closing CAPAs and ensuring regulatory compliance.
• Familiarity with TMF audits and SOPs.

Responsibilities

• Plan and execute audits of clinical studies per audit plan.
• Prepare audit reports, verify compliance, and close CAPA.
• Audit in-process activities for IMP distribution, dispensing and retention.
• Perform TMF audits and review essential documents.
• Review study protocols, Case Report Forms (CRFs) and Informed Consent Forms.
• Support Sr. Auditor in sponsor/client audits and regulatory inspections.

Skills

ICH-GCP

Clinical audits

CAPA closure

Documentation review

Job description

Job Responsibility

Description

Planning and Execution

To prepare audit plan, audit report compilation, compliance verification, corrective and preventative actions (CAPA) closure of

• Study based audits for clinical studies (including phase 1 and patient based, BA/BE studies) as per audit plan in compliance with ICH-GCP, Indian GCP, internal procedures, protocol and applicable regulatory requirements.
• Clinical studies audit and releasing audit certificate.
• In-process audits of IMP distribution, dispensing & retention
• TMF audits
• To conduct audit as per SOP & QA audit plan
• To perform essential documents, review for clinical studies (including phase 1 and BA/BE studies) in compliance with ICH-GCP, Indian GCP, internal procedures, protocol and applicable regulatory requirements.
• Protocol and Case Report Form Review
• Informed Consent Form review
• Study specific plan review (e.g. Project Management Plan, Data Management Plan, SAP (statistical analysis plan, etc.)
• Clinical Study Report (which includes biostatistics reports) Review

Quality Management System

• SOP review of Quality Assurance SOPs and review of applicable system SOPs.
• To review Change Control, Deviation
• To review of incident/ event / investigations
• To assist in software validation activities as a QA role.
• To ensure the controlling and distribution and QA data archiving activities.

Other QAD activities

• Interpretation of guidelines and regulations
• To assist Sr. Auditor in sponsor/client audits and regulatory inspections as and when required.
• Any other task assigned by reporting authority.
• To update tracker as per work delegation by Sr. Auditor.