Key Responsibilities:

1. Quality & Accreditation Responsibilities

- Conduct laboratory Gap Assessment against NABL and ISO 15189:2022 requirements.

- Develop, review and implement Quality Manuals, QSPs, SOPs, formats and records.

- Support implementation of Laboratory Quality Management Systems.

- Conduct staff awareness and training programmes.

- Support risk management, quality indicators, IQC, EQA/PT and competency assessment.

2. Audit & Compliance Responsibilities

- Conduct internal audits and prepare audit reports.

- Identify non-conformities and support Root Cause Analysis and CAPA.

- Monitor implementation and closure of identified gaps.

- Support Management Review and quality improvement activities.

3. NABL Assessment Support

- Support NABL application and documentation.

- Prepare laboratories for NABL assessment/pre-assessment.

- Assist in responding to NABL observations and closure of non-conformities.

- Maintain project trackers, reports and compliance records.

Required Qualifications

- Graduate/Postgraduate in Medical Laboratory Technology, Microbiology, Biochemistry, Biotechnology, Life Sciences or a relevant discipline.





- Training/qualification in ISO 15189:2022 preferred.

- NABL/Internal Auditor training will be an added advantage.

Experience:

- Minimum 2-5 years of relevant experience in NABL, ISO 15189, laboratory quality management or accreditation consultancy.

- Experience in NABL implementation/accreditation projects preferred

Required Skills:

- Robust knowledge of NABL and ISO 15189:2022 requirements.

- Good documentation and report-writing skills.

- Internal auditing and CAPA skills.

- Strong communication, training and coordination abilities.

- Proficiency in MS Word, Excel and PowerPoint.

- Willingness to travel to client laboratories as required.

Preferred Skills:

- Previous experience in NABL consultancy/accreditation projects.

- Certificate on Medical Laboratory System and Internal Audit as per ISO 15189: 2022 will get preference.

- Experience with medical colleges, hospitals, diagnostic laboratories or reference laboratories.

- Knowledge of laboratory risk management, IQC, EQA/PT and quality indicators.

- Strong client-handling and project management skills.

📌 Quality Consultant (Mumbai)
🏢 Integra Ventures
📍 Mumbai