Job Purpose

To support the Quality Manager in maintaining and improving the Laboratory Quality Management System (QMS) in accordance with ISO 15189:2022, NABL requirements and applicable regulatory requirements.

Key Responsibilities

- Assist in implementation, monitoring and continual improvement of the QMS.
- Monitor compliance with approved SOPs, policies, procedures and quality requirements across laboratory sections.
- Conduct/support internal audits and follow up on audit findings and corrective actions.
- Identify, document and investigate non-conformities, incidents and quality deviations and coordinate CAPA.
- Monitor quality indicators including sample rejection, TAT, report corrections, critical-value reporting, complaints and other defined indicators.
- Support monitoring of IQC, EQAS/PT performance and follow-up of unacceptable results.
- Maintain and control quality documents, records, forms and registers, ensuring current versions are available.
- Assist with NABL/ISO assessments, including preparation of required documents, records and evidence.
- Monitor implementation and effectiveness of corrective and preventive actions.
- Assist in risk assessment, complaint management and incident investigation.
- Support quality-related training, competency and awareness activities.




- Prepare periodic quality reports and data for Quality Review/Management Review.
- Identify process gaps and recommend opportunities for quality improvement.
- Escalate significant quality or patient-safety concerns to the Quality Manager/Laboratory Director.

Qualification & Experience

- Bachelor's/Master's degree in Medical Laboratory Technology, Life Sciences, Biotechnology, Biochemistry, Microbiology or related field.
- 3–5 years' relevant experience, preferably in a NABL-accredited medical laboratory.
- Knowledge of ISO 15189, NABL requirements, internal audits, CAPA, IQC/EQAS and QMS documentation preferred.

Key Skills

Quality Management | Internal Auditing | CAPA & Root Cause Analysis | Documentation | Data Analysis | NABL Compliance | Communication | Problem Solving | Attention to Detail

Authority

The Assistant Quality Manager may raise non-conformities, initiate quality investigations, recommend corrective actions and escalate significant quality risks, within the authority delegated by the Quality Manager.

Final authority for QMS decisions and CAPA closure rests with the Quality Manager/Laboratory Director as per the delegation matrix.

Pay: Up to ₹21,000.00 per month

Work Location: In person

📌 Assistant Quality Manager (Okhla)
🏢 IMMUNO DIAGNOSTICS
📍 Okhla