Auditor

Job Purpose:

The QA Auditor is responsible for evaluating and ensuring compliance with applicable regulatory standards, including Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP), across clinical research and laboratory operations. This role supports the organization's commitment to quality and regulatory integrity by conducting internal and external audits, identifying non-compliance, and driving corrective and preventive actions. The QA Auditor plays a critical role in maintaining high standards of data integrity, patient safety, and regulatory compliance, while supporting continuous quality improvement in alignment with international guidelines and sponsor expectations.

Role & responsibilities:

1. Planning, Execution, and Oversight

• QA review of protocols, study/validation plan, and amendments, if any.
• Audit Planning and Management
• To plan & conduct in-process audit of studies and method validation to assure compliance with WHO-GCLP & applicable principles of GLP and ICH-GCP, SOPs, protocol, study plan/validation plan, STP, and applicable regulatory guidelines.
• Conduct retrospective audit of study raw data & report and validation raw data & report to assure compliance with WHO-GCLP and applicable principles of GLP & ICH-GCP, SOPs, protocol, study/validation plan & applicable regulatory guidelines, and prepare QA statement/authentication.
• To conduct system audit of various departments as per pre-defined schedule to assure compliance as per in-house SOPs and prepare & communicate audit report.
• Vendor audits/supplier audits.
• To review the Analytical and functional characterization data

2. Oversight of QMS

• Review of SOPs
• Monitoring and review of deviations
• Monitoring and review of change controls
• Monitoring corrective and preventive action

3. Assist in Sponsor Audits/Client & Regulatory Inspections

• To assist Lead, QA/designee to host sponsor/client audits and regulatory inspections.
• To assist Lead, QA/designee to address sponsor/client audit response as well as its closure (as applicable).
• To assist Lead, QA/designee to review regulatory audit response and queries as well as its closure (as applicable).
• To assist Lead, QA/designee to track, prepare and submit regulatory applications and follow-up until its approval.

4. Review & Monitoring

• To prepare and review quality assurance SOPs and review applicable operational SOPs.
• To review and provide inputs on audit reports prepared by QA team for delegated audits.
• To ensure closure of all raised observations and provide QA authentication.
• To ensure the controlling and distribution and QA data archiving.
• To ensure the controlling and distribution of documents.
• To update quality manual & its annexure periodically
• To assist Lead, QA/designee for trend analysis and quality review meetings.

5. Training & Development

• To train the new joiner in QA department on various QA aspects as well study/validation aspects as applicable.
• Maintain quality culture within department.

6. Other Responsibilities

Any other responsibilities assigned by head, quality assurance/designee