Junior Auditor- BRQA

Veeda CR; Ahmedabad District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Veeda CR in Ahmedabad is looking for a QA auditor to lead audit planning and execution for study and method validation activities, ensuring adherence to ICH-GCP, Indian GCP, and internal procedures. You will manage study-based audits, release QA certificates, and prepare QA authentication documents.

The role encompasses BSP/MVP review, SOP and lab manual checks, in-process audits of sample management and batch processing, and investigations with CAPA closure.

Qualifications

• Audit planning and management for conduct, report and CAPA closure of study-based audits.
• Bioanalytical study audit and releasing QA certificates and statements.
• Review of BSP, MVP and related amendments, SOPs and lab documentation.
• In-process audits of sample management, batch processing and QC sample prep.
• Investigation support for incidents/events and retrospective data reviews.

Responsibilities

• Audit planning and management on conduct, report, compliance verification, CAPA closure of study based audits.
• Bioanalytical study audit and releasing audit certificate/QA statement.
• Preparation of QA authentication document for study.
• Review of BSP and its amendments.
• Review of MVP and its amendments.
• Review of Method SOP and Method Book; Lab manual review.
• In-process audits of sample management, stock weighing, Spiking solution preparation, CC standards, QC samples.
• Audit investigations and ISR, studies on stability and MV related activities.
• Retrospective audit of Project sample analysis and Method validation raw data and reports.
• Assist Auditor/Sr. Auditor in review of study-based activities.
• Incident/event investigations and change control/deviation review assistance.
• Assist in QA data archiving and tracker updates.

Job description

Job Responsibility

Description

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.