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.

📌 Junior Auditor - CRQA (Ahmedabad)
🏢 Veeda CR
📍 Ahmedabad