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