Junior Auditor - CRQA

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.