Quality Consultant

Integra Ventures; Mumbai; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Integra Ventures is seeking a qualified professional to lead NABL and ISO 15189 quality initiatives across laboratories in Mumbai. The role involves gap assessments, documentation, and implementing quality management systems, with a focus on training, auditing, and CAPA.

The ideal candidate has 2–5 years experience in NABL/ISO 15189 projects, strong documentation skills, and willingness to travel to client labs. ISO 15189:2022 training and NABL audits are valued.

Qualifications

• Bachelor's or master's in MLT, Microbiology, Biochemistry, Biotechnology, or Life Sciences or related discipline.
• ISO 15189:2022 training preferred.
• NABL/internal auditor training adds value.

Responsibilities

• Conduct NABL and ISO 15189 gap assessments.
• 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 CAPA.
• Perform internal audits and prepare audit reports.
• Identify non-conformities and support root cause analysis and CAPA.
• Monitor closure of identified gaps and support Management Review.
• Assist NABL applications and documentation; prepare for assessments.
• Maintain project trackers, reports and compliance records.

Skills

NABL ISO15189

Documentation

Internal auditing

CAPA skills

Communication

MS Office

Travel willingness

Education

Graduate in MLT/Life Sciences

ISO 15189 training preferred

NABL/Internal Auditor training

Tools

MS Word

MS Excel

PowerPoint

Job description

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:

• 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.