Quality Assurance

22 hours ago

Delhi, Delhi, India RECEX Full time ₹ 5,00,000 - ₹ 15,00,000 per year


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 Good 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.


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