Audit Planning and Execution of 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.