QA/QC Executive

1 week ago

Ahmedabad, Gujarat, India Unipath Specialty Laboratory Ltd. Full time ₹ 5,00,000 - ₹ 10,00,000 per year

Role Overview

The QA/QC Executive will be responsible for ensuring the quality, accuracy, and reliability of laboratory operations in compliance with NABL & ISO guidelines. The role involves monitoring quality management systems, conducting internal audits, reviewing quality indicators, ensuring documentation control, and supporting continuous improvement initiatives within the laboratory.

Key Responsibilities

Quality Assurance (QA):

  • Implement, monitor, and maintain the Quality Management System (QMS) as per NABL & ISO requirements.

  • Assist in preparation, revision, and control of SOPs, quality manuals, and other controlled documents.

  • Conduct internal audits, coordinate external audits, and ensure timely closure of non-conformities (NCs).

  • Support laboratory personnel during NABL assessments and surveillance audits.

  • Maintain records of corrective action, preventive action (CAPA), and management review meetings.

  • Monitor quality indicators, turn-around time (TAT), and customer feedback for continuous improvement.

Quality Control (QC):

  • Oversee daily QC activities, including IQC review, corrective actions, and result validation.

  • Ensure proper participation in Proficiency Testing (PT) and Inter-Laboratory Comparison (ILC) programs, and review results.

  • Support verification, calibration, and periodic maintenance of laboratory instruments and equipment.

  • Monitor reagent performance, lot-to-lot validation, and ensure proper documentation.

  • Assist technical teams in troubleshooting QC failures and implementing corrective actions.

Documentation & Compliance:

  • Maintain updated documentation as per ISO standards.

  • Ensure compliance with NABL guidelines, statutory requirements, and internal policies.

  • Maintain incident logs, deviation reports, risk assessments, and quality records.

Training & Coordination:

  • Conduct or coordinate periodic training on QMS, safety, SOPs, and quality practices.

  • Work closely with technical teams, management, and support functions for smooth operations.

Required Qualifications & Skills

Education:

  • B.Sc. / M.Sc. in Medical Laboratory Technology, Biotechnology, Microbiology, Biochemistry, or related field.

Experience:

  • 2–4 years of experience in QA/QC roles in a NABL-accredited (ISO) laboratory.

  • Experience in internal auditing, QC processes, and documentation preferred.

Technical Skills:

  • Good understanding of ISO standards.

  • Proficiency in QC analysis, PT/ILC management, and audit processes.

  • Familiarity with LIS (Laboratory Information Systems) and quality data reporting.

Soft Skills:

  • Strong communication and documentation skills.

  • Analytical thinking and problem-solving abilities.

  • Ability to multitask and work collaboratively with teams.

Job Type: Full-time

Benefits:

  • Provident Fund

Work Location: In person

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