:

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)
🏢 Veeda CR
📍 Ahmedabad