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Audit Planning &
Execution
Plan, execute, and document study-based audits in alignment with internal SOPs, study protocols, and applicable regulatory guidelines.
Conduct bioanalytical and analytical study audits, including inprocess, retrospective, sample analysis, and method validation audits; issue audit certificates/QAD statements.
Prepare audit reports, verify compliance, and ensure timely closure of corrective and preventive actions (CAPA).

Perform system audits and vendor/supplier audits, ensuring timely reporting, compliance verification, and Quality Management System (QMS)
Review, update, and finalize Quality Assurance SOPs, and evaluate functional SOPs for compliance and accuracy.
Assess CAPA, Change Controls, Deviations, and Incident/Investigation reports; recommend process improvements.
Identify process gaps through system audits and support trend analysis activities.
Support software/ system validation activities from a QA perspective and ensure proper control, distribution, and archiving of QA data.





Study Documentation &
Technical Reviews
Review method validation protocols (MVPs), bioanalytical study plans, amendments, lab manuals, and method SOPs.
Ensure alignment of technical documentation with current regulatory requirements and sponsor expectations.

Compliance, Process Oversight &
Continuous Improvement
Conduct routine checks to ensure inspection readiness and adherence to QA procedures across delegated areas.
Maintain necessary audit, QMS, and tracking record accurately and on schedule.
Interpret regulatory guidelines and support the team in applying updated requirements.
Contribute to departmental initiatives, process optimization, and quality enhancement activities.

Cross-functional Support &
Other Responsibilities
Collaborate with functional teams to strengthen compliance culture and maintain operational quality.

📌 Junior Auditor Ahmedabad (India)
🏢 Veeda CR
📍 India