Junior Auditor

Job Description:

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.