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Job Description
Planning and Execution
- Audit Planning and management on conduct, report, compliance verification, corrective and preventative actions (CAPA) closure of
Study based audits (including phase 1 and BA/BE studies) as per audit plan in compliance with ICH -GCP, Indian GCP, protocol and applicable regulatory requirements.
In-process audits of sample management, batch processing, repeat, 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 in conducting external quality assurance audits/ third party quality assurance audits.
Bioanalytical/Analytical Study Plan and its amendment Review.
Method Validation Protocol and its amendment Review.
To assist Auditor/Sr. Auditor in Lab manual review.
To assist Auditor/Sr. Auditor in Method SOP and Method Book Review.
Conduct system and vendor audits
• Audit Planning, conduct, report compilation, compliance verification, corrective and preventative actions (CAPA) closure and management of
To assist System Audits in consultation with Auditor/Sr. Auditor.
To assist Auditor/Sr. Auditor in Vendor audits.
Quality Management System
- SOP review, update and finalization of Quality Assurance SOPs and review of applicable system SOPs.
To assist Auditor/Sr. Auditor in CAPA, Change Control, Deviation Management and process improvement.
To assist Auditor/Sr. Auditor in review of incident/ event / investigations.
To assist System audit and identification of process gaps.
To assist Auditor/Sr. Auditor in Trend Analysis Reports.
To assist Auditor/Sr. Auditor 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/ lead 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 / lead auditor.
Skills
Ba/Be StudiesCapaChange ControlICH-GCP GuidelinesMethod ValidationProtocol ReviewDeviationICH-GCPAuditAudit PlanningAssuranceAuditsCapaChange ControlMethod ValidationQaQadProcess ImprovementQuality AssuranceQuality ManagementReportingSop ReviewSopsSystem AuditIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
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