Key Responsibilities:
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.
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.
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 4–5 years of relevant experience in NABL, ISO 15189, laboratory quality management or accreditation consultancy.
- Experience in NABL implementation/accreditation projects preferred.
Required Skills:
- Strong 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.
Pay: ₹30,000.00 - ₹50,000.00 per month
Benefits:
- Cell phone reimbursement
- Health insurance
- Leave encashment
- Provident Fund
Work Location: In person
