Job Description: Key Responsibilities:
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).
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.
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.
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.
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:
Solid attention to detail and documentation accuracy.
Analytical thinking and problem-solving skills.
Valuable 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