Technical Auditor

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 on-site 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 [HIDDEN TEXT]