Quality Assurance

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.