Junior Auditor- BRQA

Job Responsibility

Description

Audit Planning and Executionof Study/Method Validation related activities:

Audit Planning and management on conduct, report, compliance verification, corrective and preventative actions (CAPA) closure of

• Study based audits (including phase 1, BA/BE studies and patient-based studies) as per audit plan in compliance with ICH-GCP, Indian GCP, Internal procedures, protocol and applicable regulatory requirements.
• Bioanalytical study audit and releasing audit certificate/QA statement.
• Preparation of QA authentication document for study.
• Bioanalytical Study Plan (BSP) and its amendment Review
• Method Validation Protocol (MVP) and its amendment Review
• Method SOP and Method Book Review.
• Lab manual review.
• In-process audits of sample management, Stock weighing, Spiking solution preparation, CC Standards and QC sample preparation, batch processing, repeat analysis, investigations, ISR, MV related activities like P&A batches, stability experiments.
• Retrospective audit of Project sample analysis and Method validation raw data and its respective reports.
• To assist Auditor/Sr. Auditor in review of study-based

Incident/event / Investigations.

Quality Management System

• To assist Auditor/Sr. Auditor in Change Control, Deviation Review
• To ensure the controlling and distribution and QA data archiving activities.

Other QAD activities

• Any other task assigned by reporting authority.
• To update tracker as per work delegation by Auditor/Sr. auditor.