We're looking for a Technical Auditor to lead internal audits across our Pathology, Genomics, and IVF laboratories and help us maintain the highest standards of regulatory & technical excellence.

What You'll Do

Audit Planning & Execution

· Build & run annual audit calendars across Pathology, Genomics & IVF labs

· Conduct scheduled, surprise and follow-up audits against NABL/ISO 15189:2022, ISO 15190, ISO 15195, ART (Regulation) Act 2021, and ICMR-ART guidelines

· Review pre-analytical, analytical and post-analytical workflows

· Evaluate calibration, maintenance and validation of analyzers, sequencers, PCR machines, incubators, cryostorage units and micromanipulation systems.

Lab-Specific Audit

Pathology - specimen handling, IQC/EQAS compliance, TAT and critical value reporting.

Genomics - NGS workflows, bioinformatics data integrity, contamination control, data security.

IVF - embryology procedures, witnessing protocols, cryopreservation, ART Act documentation, andrology lab review.

Research & Testing Lab Audits

· Plan & conduct in office audits of research and testing laboratories, assessing compliance with GLP/GMP, ISO 17025, biosafety, & client-defined quality standards

· Review laboratory SOPs, instrument calibration/maintenance logs, and validation records for molecular biology and genomics platforms (PCR, qPCR, Sanger/NGS sequencers, genotyping systems)





· Evaluate data integrity and traceability across experimental workflows, including sample handling & gene expression assays, from raw data to reported results

· Verify adherence to protocols for sample chain-of-custody, biological material handling, & record-keeping across high-throughput sample processing operations

· Identify non-conformances, process gaps, & risk areas; document findings in clear, technically sound audit reports with actionable CAPA recommendations

· Liaise with lab heads, principal investigators, & quality teams to walk through findings and support closure of audit observations

· Benchmark client lab practices against industry standards and evolving regulatory/scientific best practices in molecular biology and genomics

· Support pre-audit readiness, follow-up audits, and periodic surveillance visits as per the audit calendar

· Maintain audit documentation, working papers, and reporting within the firm's audit management systems and timelines

What We're Looking For

· Ph.D or M.Sc in Medical Lab Technology, Biotechnology, Genomics, Clinical Embryology, or Life Sciences

· ISO 15189 Internal/Lead Auditor certification preferred

· 3-5 years in clinical lab operations, QA, or internal auditing

· Prior NABL/CAP/ISO 15189 audit experience strongly preferred

Interested or know someone who fits? Drop a comment or send your resume at "[email protected]"

📌 Technical Auditor (Bareilly)
🏢 Corpus Consulting
📍 Bareilly