Corpus Consulting
Website:
corpusconsulting.in
Job details:
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 "vishal@corpusconsulting.in"
Click on Apply to know more.