Job Description: Key Responsibilities:

1. Quality System Management

- Implement and maintain the Quality Management System (QMS) in compliance with ISO 17025 / GLP / GMP / NABL standards.

- Prepare, review, and control QA-related documents such as SOPs, policies, forms, and records.

- Ensure timely calibration, maintenance, and validation of laboratory instruments.

- Conduct internal audits and coordinate external audits (NABL, ISO, regulatory bodies).

2. Documentation & Record Control

- Review and approve test reports, analytical data, and logbooks.

- Maintain and control document versions as per QMS.

- Ensure traceability of all samples, test methods, and data records.

3. Compliance & Regulatory

- Ensure compliance with relevant national/international standards and regulations.

- Assist in regulatory inspections and ensure prompt closure of audit observations.

- Monitor laboratory practices for adherence to GLP/GMP guidelines.

4. Training & Continuous Improvement

- Conduct and document employee training on QA policies, SOPs, and Valuable Laboratory Practices.

- Identify areas for process improvement and implement corrective and preventive actions (CAPA).





- Monitor laboratory performance through quality indicators and participate in proficiency testing programs.

5. Risk & Deviation Management

- Handle deviations, OOS (Out of Specification), and OOT (Out of Trend) investigations.

- Support in root cause analysis and ensure timely implementation of CAPAs.

Qualifications & Skills:

Experience:

- 2–6 years of experience in Quality Assurance in a testing, analytical, or research laboratory.

Technical Skills:

- Sound knowledge of ISO/IEC 17025, GLP, GMP, and NABL documentation.

- Familiarity with LIMS (Laboratory Information Management Systems).

- Understanding of instrument calibration and method validation requirements.

Soft Skills:

- Strong attention to detail and documentation accuracy.

- Analytical thinking and problem-solving skills.

- Good communication and teamwork abilities.

Work Environment:

- Laboratory-based with interaction across QA, QC, and analytical teams.

- May require periodic travel for audits or inter-lab coordination.

📌 Quality Assurance (Delhi)
🏢 RECEX
📍 Delhi