Junior Research & Compliance Auditor for SOPs & Audits

Axisclinicals; La Traine de Nioron; On-site; EUR 45,000 - 65,000; Full time

Job summary

Axisclinicals is seeking a QA/regulatory auditor to support the lifecycle of SOPs, logs, and master lists, ensuring accuracy and compliance with regulatory requirements across studies.

You will review protocols, ICFs, audits of IRB/IEC, vendor services, and study reports; coordinate internal training; handle sponsor queries; and assist with eCTD packaging and regulatory submissions to strengthen compliance.

Responsibilities

• 1. Generation, distribution, retrieval, archival of SOPs and maintenance of related records/ log books/master list of SOPs.
• 2. Issue of controlled forms and log books for use.
• 3. Training of new employees by coordinating with different departments.
• 4. Conducting Facility and System audits.
• 5. Carry out periodic inspection and audit as per SOPs.
• 6. Conducting the audit of IRB/IEC/Vendor/Third party service provider.
• 7. Review of study protocols, Informed consent Forms (ICFs) in compliance to SOPs/regulatory requirements.
• 8. Carry out In process and retrospective audit of studies.
• 9. Compilation of documents/ eCTD preparation as per the regulatory requirement to support regulatory submission.
• 10. Review of rawdata, chromatograms and reports of bioanalytical method validations and studies in compliance to SOPs.
• 11. Review of Clinical, Bio statistical and Bioanaytical reports.
• 12. Review of software and equipment validations / IQ/OQ/PQ/Calibration documents.
• 13. Handling of regulatory/ sponsor queries and responses.

Job description

Axisclinicals is seeking a QA/regulatory auditor to support the lifecycle of SOPs, logs, and master lists, ensuring accuracy and compliance with regulatory requirements across studies.

You will review protocols, ICFs, audits of IRB/IEC, vendor services, and study reports; coordinate internal training; handle sponsor queries; and assist with eCTD packaging and regulatory submissions to strengthen compliance.