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.