Website:
veedalifesciences.com
Job details:
Department: Quality Assurance
JOB DESCRIPTION
Primary Responsibility
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.
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